<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02218372</url>
  </required_header>
  <id_info>
    <org_study_id>2819-CL-0202</org_study_id>
    <secondary_id>2013-000508-40</secondary_id>
    <secondary_id>SUNSHINE</secondary_id>
    <nct_id>NCT02218372</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)</brief_title>
  <acronym>SUNSHINE</acronym>
  <official_title>A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Europe B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the clinical response to fidaxomicin oral&#xD;
      suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with&#xD;
      Clostridium difficile-associated diarrhea (CDAD). It also investigated the&#xD;
      recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well&#xD;
      as acceptance of the fidaxomicin oral suspension formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2015</start_date>
  <completion_date type="Actual">March 7, 2018</completion_date>
  <primary_completion_date type="Actual">March 7, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days</measure>
    <time_frame>Up to day 12</time_frame>
    <description>Initial clinical response (ICR) for ages from birth to &lt; 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to &lt; 18 years was defined as improvement in number and character of bowel movements as determined by &lt; 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to &lt; 2 years) or number of UBMs (for ages ≥ 2 years to &lt; 18 years).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days</measure>
    <time_frame>Up to day 19</time_frame>
    <description>SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Global Cure (GC) at EOT +9 Days</measure>
    <time_frame>Up to day 19</time_frame>
    <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Recurrence of CDAD at EOT +9 Days</measure>
    <time_frame>Up to day 19</time_frame>
    <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SCR at EOT +16 Days</measure>
    <time_frame>Up to day 26</time_frame>
    <description>SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With GC at EOT +16 Days</measure>
    <time_frame>Up to day 26</time_frame>
    <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Recurrence of CDAD at EOT +16 Days</measure>
    <time_frame>Up to day 26</time_frame>
    <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SCR at EOT +23 Days</measure>
    <time_frame>Up to day 33</time_frame>
    <description>SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With GC at EOT +23 Days</measure>
    <time_frame>Up to day 33</time_frame>
    <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Recurrence of CDAD at EOT +23 Days</measure>
    <time_frame>Up to day 33</time_frame>
    <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)</measure>
    <time_frame>Up to day 40</time_frame>
    <description>SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With GC at EOS (EOT +30 Days)</measure>
    <time_frame>Up to day 40</time_frame>
    <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)</measure>
    <time_frame>Up to day 40</time_frame>
    <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Diarrhea (TTROD)</measure>
    <time_frame>Up to day 10</time_frame>
    <description>TTROD for ages from birth &lt; 2 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to &lt; 18 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of &lt; 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days</measure>
    <time_frame>Up to day 40</time_frame>
    <description>Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From the first dose of study drug administration up to 30 days after EOT (up to day 40)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Fidaxomicin</measure>
    <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the blood samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Metabolite OP-1118</measure>
    <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the blood samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolite-to-Parent Ratio (MPRconc)</measure>
    <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the blood samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Concentrations of Fidaxomicin</measure>
    <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the stool samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Concentrations of Metabolite OP-1118</measure>
    <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the stool samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MPRconc Within 24 Hours of a Dose</measure>
    <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
    <description>Drug concentration was derived from the stool samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7</measure>
    <time_frame>Days 1 and 7</time_frame>
    <description>Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =&lt; 6 years and participants &gt; 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Clostridium Difficile-associated Diarrhea (CDAD)</condition>
  <arm_group>
    <arm_group_label>Fidaxomicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fidaxomicin oral suspension</intervention_name>
    <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.</description>
    <arm_group_label>Fidaxomicin</arm_group_label>
    <other_name>Dificid</other_name>
    <other_name>Dificlir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fidaxomicin tablets</intervention_name>
    <description>Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
    <arm_group_label>Fidaxomicin</arm_group_label>
    <other_name>Dificlir</other_name>
    <other_name>Dificid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin oral liquid</intervention_name>
    <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin capsules</intervention_name>
    <description>Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum&#xD;
             there must be positive detection, within 72 hours prior to randomization, of either&#xD;
             toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in&#xD;
             stool and:&#xD;
&#xD;
               -  Subject from Birth to &lt; 2 years: watery diarrhea in the 24 hours prior to&#xD;
                  screening.&#xD;
&#xD;
               -  Subject ≥ 2 years to &lt; 18 years: ≥ 3 unformed bowel movements in the 24 hours&#xD;
                  prior to screening.&#xD;
&#xD;
               -  Male and female subjects aged from birth to &lt; 18 years: Note that in the United&#xD;
                  States of America subjects can only be included if aged ≥ 6 months to &lt; 18 years.&#xD;
&#xD;
          -  For subjects &lt; 5 years: Negative rotavirus test.&#xD;
&#xD;
          -  Female subject of childbearing potential:&#xD;
&#xD;
               -  must have a negative urine pregnancy test at Screening, and&#xD;
&#xD;
               -  must abstain from sexual activity for the duration of the study, or&#xD;
&#xD;
               -  must use two forms of birth control (at least one of which must be a barrier&#xD;
                  method) starting at Screening and throughout the study period and for 28 days&#xD;
                  after the final study drug administration.&#xD;
&#xD;
          -  Female subject must not be breastfeeding at Screening or during the study period, and&#xD;
             for 28 days after the final study drug administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at Screening and throughout the study&#xD;
             period, and for 28 days after the final study drug administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while in the study&#xD;
             (with the exception of studies as described in exclusion criteria below).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments&#xD;
             for CDAD. If the investigator feels the clinical imperative is to begin treatment&#xD;
             before knowing the laboratory result for toxigenic C. difficile, up to four doses but&#xD;
             no more than 24 hours of treatment with metronidazole, oral vancomycin or any other&#xD;
             effective treatment for CDAD are allowed.&#xD;
&#xD;
          -  Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.&#xD;
&#xD;
          -  Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or&#xD;
             Crohn's disease etc.).&#xD;
&#xD;
          -  Subject has diarrhea caused by an agent other than C. difficile (e.g. infections,&#xD;
             infestations, drugs etc.).&#xD;
&#xD;
          -  Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or&#xD;
             to teicoplanin.&#xD;
&#xD;
          -  Subject has received an investigational therapy within 28 days, prior to Screening,&#xD;
             with the exception of studies with primary treatment for cancer without novel&#xD;
             Investigational Medicinal Product (IMP) and which do not affect the assessment of&#xD;
             diarrhea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Research Physician</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Europe B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site US10015</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10010</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10004</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10025</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10032</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10030</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10008</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10028</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10027</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10014</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10034</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10022</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-2794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10038</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US10037</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32001</name>
      <address>
        <city>Brussels</city>
        <state>Flemish Brabant</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32003</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32002</name>
      <address>
        <city>Liege</city>
        <zip>4020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA15003</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site FR33002</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site FR33001</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site FR33007</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site FR33005</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site FR33008</name>
      <address>
        <city>Strasbourg cedex</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49010</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49002</name>
      <address>
        <city>Frankfurt am M.</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49006</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49004</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49001</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site DE49003</name>
      <address>
        <city>Saint Augustin</city>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU36006</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU36004</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39004</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39001</name>
      <address>
        <city>Roma</city>
        <zip>165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48002</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>04-730</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48012</name>
      <address>
        <city>Bialystok</city>
        <zip>15 -274</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48007</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-030</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48004</name>
      <address>
        <city>Debica</city>
        <zip>39-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48014</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-210</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48006</name>
      <address>
        <city>Tarnow</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RO40005</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34002</name>
      <address>
        <city>Barcelona</city>
        <zip>8950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34007</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34004</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34003</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Slovakia</country>
  </removed_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=362</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>October 23, 2018</results_first_submitted>
  <results_first_submitted_qc>December 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 7, 2018</results_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile-associated Diarrhea (CDAD)</keyword>
  <keyword>vancomycin</keyword>
  <keyword>Clostridium difficile infection</keyword>
  <keyword>fidaxomicin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Fidaxomicin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 21, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02218372/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02218372/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Pediatric participants with clostridium difficile-associated diarrhea (CDAD) were enrolled in this multicenter study.</recruitment_details>
      <pre_assignment_details>Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled, 159 participants were assessed for eligibility of whom 148 were randomized. Participants were randomized to either fidaxomicin or vancomycin in a 2:1 ratio, stratified by age group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fidaxomicin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
        </group>
        <group group_id="P2">
          <title>Vancomycin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis set consisted of the Intent-to-treat (ITT) population. The ITT analysis set consisted of all randomized participants, irrespective of a participant having received a study drug (fidaxomicin or vancomycin) or not.</population>
      <group_list>
        <group group_id="B1">
          <title>Fidaxomicin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
        </group>
        <group group_id="B2">
          <title>Vancomycin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.7" spread="61.8"/>
                    <measurement group_id="B2" value="77.5" spread="59.2"/>
                    <measurement group_id="B3" value="79" spread="60.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days</title>
        <description>Initial clinical response (ICR) for ages from birth to &lt; 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to &lt; 18 years was defined as improvement in number and character of bowel movements as determined by &lt; 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to &lt; 2 years) or number of UBMs (for ages ≥ 2 years to &lt; 18 years).</description>
        <time_frame>Up to day 12</time_frame>
        <population>The analysis population consisted of the full analysis set (FAS) which consisted of all randomized participants who received at least 1 dose of study drug. In the FAS, participants were allocated to the treatment arm corresponding to the study medication that the participant was randomized to (treatment allocation as randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days</title>
          <description>Initial clinical response (ICR) for ages from birth to &lt; 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to &lt; 18 years was defined as improvement in number and character of bowel movements as determined by &lt; 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to &lt; 2 years) or number of UBMs (for ages ≥ 2 years to &lt; 18 years).</description>
          <population>The analysis population consisted of the full analysis set (FAS) which consisted of all randomized participants who received at least 1 dose of study drug. In the FAS, participants were allocated to the treatment arm corresponding to the study medication that the participant was randomized to (treatment allocation as randomized).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" lower_limit="68.0" upper_limit="85.4"/>
                    <measurement group_id="O2" value="70.5" lower_limit="54.8" upper_limit="83.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>7.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.4</ci_lower_limit>
            <ci_upper_limit>23.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days</title>
        <description>SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 19</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days</title>
          <description>SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="87.1" upper_limit="98.5"/>
                    <measurement group_id="O2" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>34.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Global Cure (GC) at EOT +9 Days</title>
        <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.</description>
        <time_frame>Up to day 19</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Global Cure (GC) at EOT +9 Days</title>
          <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" lower_limit="65.8" upper_limit="83.6"/>
                    <measurement group_id="O2" value="54.5" lower_limit="38.8" upper_limit="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>21.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.5</ci_lower_limit>
            <ci_upper_limit>37.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Recurrence of CDAD at EOT +9 Days</title>
        <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 19</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Recurrence of CDAD at EOT +9 Days</title>
          <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="1.5" upper_limit="12.9"/>
                    <measurement group_id="O2" value="22.6" lower_limit="9.6" upper_limit="41.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>-16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.2</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SCR at EOT +16 Days</title>
        <description>SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 26</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SCR at EOT +16 Days</title>
          <description>SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5" lower_limit="80.3" upper_limit="95.3"/>
                    <measurement group_id="O2" value="71.0" lower_limit="52.0" upper_limit="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>17.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.9</ci_lower_limit>
            <ci_upper_limit>35.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With GC at EOT +16 Days</title>
        <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.</description>
        <time_frame>Up to day 26</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With GC at EOT +16 Days</title>
          <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" lower_limit="61.4" upper_limit="80.1"/>
                    <measurement group_id="O2" value="52.3" lower_limit="36.7" upper_limit="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>19.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.3</ci_lower_limit>
            <ci_upper_limit>35.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Recurrence of CDAD at EOT +16 Days</title>
        <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 26</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Recurrence of CDAD at EOT +16 Days</title>
          <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" lower_limit="3.0" upper_limit="16.4"/>
                    <measurement group_id="O2" value="25.8" lower_limit="11.9" upper_limit="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>-17.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.6</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SCR at EOT +23 Days</title>
        <description>SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 33</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SCR at EOT +23 Days</title>
          <description>SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" lower_limit="75.6" upper_limit="92.5"/>
                    <measurement group_id="O2" value="71.0" lower_limit="52.0" upper_limit="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>15.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>34.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With GC at EOT +23 Days</title>
        <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.</description>
        <time_frame>Up to day 33</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With GC at EOT +23 Days</title>
          <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" lower_limit="58.2" upper_limit="77.4"/>
                    <measurement group_id="O2" value="50.0" lower_limit="34.6" upper_limit="65.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>18.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>35.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Recurrence of CDAD at EOT +23 Days</title>
        <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 33</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Recurrence of CDAD at EOT +23 Days</title>
          <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="5.6" upper_limit="21.3"/>
                    <measurement group_id="O2" value="29.0" lower_limit="14.2" upper_limit="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>-15.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)</title>
        <description>SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 40</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)</title>
          <description>SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" lower_limit="75.6" upper_limit="92.5"/>
                    <measurement group_id="O2" value="71.0" lower_limit="52.0" upper_limit="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>15.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>34.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With GC at EOS (EOT +30 Days)</title>
        <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.</description>
        <time_frame>Up to day 40</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With GC at EOS (EOT +30 Days)</title>
          <description>GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" lower_limit="58.2" upper_limit="77.4"/>
                    <measurement group_id="O2" value="50.0" lower_limit="34.6" upper_limit="65.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>adjusted treatment difference</param_type>
            <param_value>18.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>35.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)</title>
        <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
        <time_frame>Up to day 40</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)</title>
          <description>Recurrence for ages from birth to &lt; 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years &lt; 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="5.6" upper_limit="21.3"/>
                    <measurement group_id="O2" value="29.0" lower_limit="14.2" upper_limit="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Newcombe 95% CIs presented for adjusted treatment difference.</non_inferiority_desc>
            <param_type>adjusted treatment difference</param_type>
            <param_value>-15.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Diarrhea (TTROD)</title>
        <description>TTROD for ages from birth &lt; 2 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to &lt; 18 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of &lt; 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.</description>
        <time_frame>Up to day 10</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Diarrhea (TTROD)</title>
          <description>TTROD for ages from birth &lt; 2 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to &lt; 18 years was defined as time elapsing (hours rounded up from minutes &gt; 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of &lt; 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" lower_limit="29.0" upper_limit="122.0"/>
                    <measurement group_id="O2" value="97" lower_limit="42.0" upper_limit="146.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Time to resolution of diarrhea.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.579</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days</title>
        <description>Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.</description>
        <time_frame>Up to day 40</time_frame>
        <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days</title>
          <description>Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.</description>
          <population>The analysis population consisted of the FAS (participants with CCR at EOT +2 days).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" lower_limit="NA" upper_limit="NA">Data for Median was estimated and the 95% CI could not be estimated due to low event rate.</measurement>
                    <measurement group_id="O2" value="26" lower_limit="NA" upper_limit="NA">Data for Median was estimated and the 95% CI could not be estimated due to low event rate.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Time to recurrence of CDAD.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.023</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.</description>
        <time_frame>From the first dose of study drug administration up to 30 days after EOT (up to day 40)</time_frame>
        <population>The analysis population consisted of the safety analysis set (SAF), which consisted of all randomized participants who received at least 1 study drug dose. In the SAF, participants were allocated to the treatment arm corresponding to study drug first administered (fidaxomicin or vancomycin), even if it differed from the treatment randomized to.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin</title>
            <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.</description>
          <population>The analysis population consisted of the safety analysis set (SAF), which consisted of all randomized participants who received at least 1 study drug dose. In the SAF, participants were allocated to the treatment arm corresponding to study drug first administered (fidaxomicin or vancomycin), even if it differed from the treatment randomized to.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related Moderate TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related Mild TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to Withdrawal of Treatment (Tx)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE Leading to Withdrawal of Tx</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Fidaxomicin</title>
        <description>Drug concentration was derived from the blood samples collected.</description>
        <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the pharmacokinetics analysis set (PKAS). The PKAS consisted of all participants randomized to fidaxomicin, having received at least 1 dose of fidaxomicin and having at least 1 valid measurement of plasma concentration or fecal concentration of fidaxomicin or its main metabolite OP-1118.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Fidaxomicin</title>
          <description>Drug concentration was derived from the blood samples collected.</description>
          <population>The analysis population consisted of the pharmacokinetics analysis set (PKAS). The PKAS consisted of all participants randomized to fidaxomicin, having received at least 1 dose of fidaxomicin and having at least 1 valid measurement of plasma concentration or fecal concentration of fidaxomicin or its main metabolite OP-1118.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.17" spread="40.16"/>
                    <measurement group_id="O2" value="15.26" spread="20.43"/>
                    <measurement group_id="O3" value="30.16" spread="63.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.41" spread="62.15"/>
                    <measurement group_id="O2" value="34.60" spread="57.79"/>
                    <measurement group_id="O3" value="48.53" spread="69.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Metabolite OP-1118</title>
        <description>Drug concentration was derived from the blood samples collected.</description>
        <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Metabolite OP-1118</title>
          <description>Drug concentration was derived from the blood samples collected.</description>
          <population>The analysis population consisted of the PKAS.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.04" spread="171.97"/>
                    <measurement group_id="O2" value="42.18" spread="76.76"/>
                    <measurement group_id="O3" value="105.54" spread="277.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.64" spread="259.10"/>
                    <measurement group_id="O2" value="102.38" spread="245.19"/>
                    <measurement group_id="O3" value="143.63" spread="286.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolite-to-Parent Ratio (MPRconc)</title>
        <description>Drug concentration was derived from the blood samples collected.</description>
        <time_frame>Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolite-to-Parent Ratio (MPRconc)</title>
          <description>Drug concentration was derived from the blood samples collected.</description>
          <population>The analysis population consisted of the PKAS.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="1.42"/>
                    <measurement group_id="O2" value="3.24" spread="1.46"/>
                    <measurement group_id="O3" value="3.05" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" spread="1.18"/>
                    <measurement group_id="O2" value="2.95" spread="1.23"/>
                    <measurement group_id="O3" value="2.69" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fecal Concentrations of Fidaxomicin</title>
        <description>Drug concentration was derived from the stool samples collected.</description>
        <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Concentrations of Fidaxomicin</title>
          <description>Drug concentration was derived from the stool samples collected.</description>
          <population>The analysis population consisted of the PKAS.</population>
          <units>μg/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2685.56" spread="2476.92"/>
                    <measurement group_id="O2" value="2969.87" spread="2713.58"/>
                    <measurement group_id="O3" value="2190.63" spread="1948.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fecal Concentrations of Metabolite OP-1118</title>
        <description>Drug concentration was derived from the stool samples collected.</description>
        <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Concentrations of Metabolite OP-1118</title>
          <description>Drug concentration was derived from the stool samples collected.</description>
          <population>The analysis population consisted of the PKAS.</population>
          <units>μg/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="889.23" spread="817.83"/>
                    <measurement group_id="O2" value="789.15" spread="728.58"/>
                    <measurement group_id="O3" value="1059.73" spread="941.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MPRconc Within 24 Hours of a Dose</title>
        <description>Drug concentration was derived from the stool samples collected.</description>
        <time_frame>Within 24 hours of a dose taken between day 5 and day 10</time_frame>
        <population>The analysis population consisted of the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomin All Formulations</title>
            <description>Participants received either fidaxomicin oral suspension or tablet formulation.</description>
          </group>
          <group group_id="O2">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O3">
            <title>Fidaxomicin Tablets</title>
            <description>Participants received fidaxomicin tablets formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>MPRconc Within 24 Hours of a Dose</title>
          <description>Drug concentration was derived from the stool samples collected.</description>
          <population>The analysis population consisted of the PKAS.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.31"/>
                    <measurement group_id="O2" value="0.32" spread="0.19"/>
                    <measurement group_id="O3" value="0.63" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7</title>
        <description>Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =&lt; 6 years and participants &gt; 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.</description>
        <time_frame>Days 1 and 7</time_frame>
        <population>The analysis population consisted of the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin Oral Suspension</title>
            <description>Participants received fidaxomicin oral suspension formulation.</description>
          </group>
          <group group_id="O2">
            <title>Vancomycin Oral Liquid</title>
            <description>Participants received vancomycin oral liquid formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7</title>
          <description>Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =&lt; 6 years and participants &gt; 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.</description>
          <population>The analysis population consisted of the FAS.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 Awful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Awful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study drug administration up to 30 days after EOT (up to day 40)</time_frame>
      <desc>The total number of deaths (all causes) includes deaths reported after time frame above.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fidaxomicin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.</description>
        </group>
        <group group_id="E2">
          <title>Vancomycin</title>
          <description>Participants from birth to &lt; 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to &lt; 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Mitochondrial encephalomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Gastrointestinal necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Fungal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Herpes simplex meningoencephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Scedosporium infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Malignant ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Radiotherapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="98"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="98"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="11" subjects_at_risk="98"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure</name_or_title>
      <organization>Astellas Pharma Global Development, Inc.</organization>
      <phone>800-888-7704</phone>
      <email>astellas.resultsdisclosure@astellas.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02218372
org study id: 2819-CL-0202
secondary id: 2013-000508-40
secondary id: SUNSHINE
nct id: NCT02218372
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to investigate the clinical response to fidaxomicin oral
      suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with
      Clostridium difficile-associated diarrhea (CDAD). It also investigated the
      recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well
      as acceptance of the fidaxomicin oral suspension formulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days
time frame: Up to day 12
description: Initial clinical response (ICR) for ages from birth to < 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to < 18 years was defined as improvement in number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to < 2 years) or number of UBMs (for ages ≥ 2 years to < 18 years).
measure: Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days
time frame: Up to day 19
description: SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With Global Cure (GC) at EOT +9 Days
time frame: Up to day 19
description: GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.
measure: Percentage of Participants With Recurrence of CDAD at EOT +9 Days
time frame: Up to day 19
description: Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With SCR at EOT +16 Days
time frame: Up to day 26
description: SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With GC at EOT +16 Days
time frame: Up to day 26
description: GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.
measure: Percentage of Participants With Recurrence of CDAD at EOT +16 Days
time frame: Up to day 26
description: Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With SCR at EOT +23 Days
time frame: Up to day 33
description: SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With GC at EOT +23 Days
time frame: Up to day 33
description: GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.
measure: Percentage of Participants With Recurrence of CDAD at EOT +23 Days
time frame: Up to day 33
description: Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)
time frame: Up to day 40
description: SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Percentage of Participants With GC at EOS (EOT +30 Days)
time frame: Up to day 40
description: GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.
measure: Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)
time frame: Up to day 40
description: Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.
measure: Time to Resolution of Diarrhea (TTROD)
time frame: Up to day 10
description: TTROD for ages from birth < 2 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to < 18 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of < 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.
measure: Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days
time frame: Up to day 40
description: Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.
measure: Number of Participants With Adverse Events (AEs)
time frame: From the first dose of study drug administration up to 30 days after EOT (up to day 40)
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.
measure: Plasma Concentrations of Fidaxomicin
time frame: Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
description: Drug concentration was derived from the blood samples collected.
measure: Plasma Concentrations of Metabolite OP-1118
time frame: Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
description: Drug concentration was derived from the blood samples collected.
measure: Metabolite-to-Parent Ratio (MPRconc)
time frame: Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
description: Drug concentration was derived from the blood samples collected.
measure: Fecal Concentrations of Fidaxomicin
time frame: Within 24 hours of a dose taken between day 5 and day 10
description: Drug concentration was derived from the stool samples collected.
measure: Fecal Concentrations of Metabolite OP-1118
time frame: Within 24 hours of a dose taken between day 5 and day 10
description: Drug concentration was derived from the stool samples collected.
measure: MPRconc Within 24 Hours of a Dose
time frame: Within 24 hours of a dose taken between day 5 and day 10
description: Drug concentration was derived from the stool samples collected.
measure: Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7
time frame: Days 1 and 7
description: Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =< 6 years and participants > 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.
arm group label: Fidaxomicin
arm group type: Experimental
description: Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
arm group label: Vancomycin
arm group type: Active Comparator
description: Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
intervention type: Drug
intervention name: Fidaxomicin oral suspension
description: Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.
arm group label: Fidaxomicin
other name: Dificid
other name: Dificlir
intervention type: Drug
intervention name: Fidaxomicin tablets
description: Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
arm group label: Fidaxomicin
other name: Dificlir
other name: Dificid
intervention type: Drug
intervention name: Vancomycin oral liquid
description: Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.
arm group label: Vancomycin
intervention type: Drug
intervention name: Vancomycin capsules
description: Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
arm group label: Vancomycin
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Clinical Research Physician
role: Study Director
affiliation: Astellas Pharma Europe B.V.
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country: Belgium
country: Canada
country: France
country: Germany
country: Hungary
country: Italy
country: Poland
country: Romania
country: Spain
country: United States
country: Slovakia
url: https://astellasclinicalstudyresults.com/study.aspx?ID=362
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Diarrhea
mesh term: Vancomycin
mesh term: Fidaxomicin
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: https://www.clinicalstudydatarequest.com/
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