<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/NCT02254967</url>
  </required_header>
  <id_info>
    <org_study_id>2819-MA-1002</org_study_id>
    <secondary_id>2013-004619-31</secondary_id>
    <nct_id>NCT02254967</nct_id>
  </id_info>
  <brief_title>A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population</brief_title>
  <acronym>EXTEND</acronym>
  <official_title>A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Europe Ltd.</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to evaluate whether the extended duration fidaxomicin&#xD;
      therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at&#xD;
      30 days after end of treatment (Day 40 or Day 55).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2014</start_date>
  <completion_date type="Actual">May 5, 2016</completion_date>
  <primary_completion_date type="Actual">March 27, 2016</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment</measure>
    <time_frame>Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])</time_frame>
    <description>Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90</measure>
    <time_frame>Day 40, 55, 90</time_frame>
    <description>Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the ESCMID criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment</measure>
    <time_frame>Day 12, 27</time_frame>
    <description>Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Clinical Response of CDI at Day 12</measure>
    <time_frame>Day 12</time_frame>
    <description>Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates</measure>
    <time_frame>Baseline through day 90</time_frame>
    <description>For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Diarrhea (TTROD)</measure>
    <time_frame>Up to day 10 (for vancomycin) or up to day 25 (for EPFX)</time_frame>
    <description>Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes &gt; 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, &gt; 50% reduction in number of stools or &gt; 75% reduction in volume of liquid stool) that are sustained through to TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90</measure>
    <time_frame>Day 40, 55, 90</time_frame>
    <description>For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of CDI after End of Active Treatment</measure>
    <time_frame>From day 10 up to day 90</time_frame>
    <description>Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival After Day 10</measure>
    <time_frame>From day 10 up to day 90</time_frame>
    <description>Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Clostridium Difficile</condition>
  <arm_group>
    <arm_group_label>Fidaxomicin Extended Pulsed Regimen (EPFX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fidaxomicin</intervention_name>
    <description>oral tablets administered in an extended pulsed regimen</description>
    <arm_group_label>Fidaxomicin Extended Pulsed Regimen (EPFX)</arm_group_label>
    <other_name>OPT-80</other_name>
    <other_name>ASP2819</other_name>
    <other_name>Dificlir</other_name>
    <other_name>Dificid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Vancomycin</arm_group_label>
    <other_name>Vancocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CDI is confirmed by clinical symptoms (either &gt; 3 unformed bowel movements or ≥ 200ml&#xD;
             of unformed stool (for subjects having rectal collection devices)) in the 24 hours&#xD;
             prior to randomization and CDI test confirmed positive for presence of C. difficile&#xD;
             toxin A or B in stool within 48 hr prior to randomization.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study whilst participating&#xD;
             in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is taking or requiring to be treated with prohibited medications&#xD;
&#xD;
          -  Subject has received more than one day of dosing of any therapy for CDI within the&#xD;
             last 48 hours&#xD;
&#xD;
          -  Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to&#xD;
             study enrolment&#xD;
&#xD;
          -  Subject is unable to swallow oral study medication.&#xD;
&#xD;
          -  Subject has a current diagnosis of toxic megacolon.&#xD;
&#xD;
          -  Subject is not willing to adhere to the provisions of treatment and observation&#xD;
             specified in the protocol.&#xD;
&#xD;
          -  Subject has been randomized into this study previously, has taken any investigational&#xD;
             drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is&#xD;
             currently participating in another clinical study which may influence the assessment&#xD;
             of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.&#xD;
&#xD;
          -  Subject has previously participated in a CDI vaccine study&#xD;
&#xD;
          -  Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Europe Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site AT43002</name>
      <address>
        <city>Graz</city>
        <zip>8020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site AT43003</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site AT43001</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32007</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32006</name>
      <address>
        <city>Brugge</city>
        <zip>B-8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32001</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Site BE32005</name>
      <address>
        <city>Brussels</city>
        <zip>B-1020</zip>
        <country>Belgium</country>
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    <facility>
      <name>Site BE32008</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
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    <facility>
      <name>Site HR38506</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
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      <name>Site HR38503</name>
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      <name>Site HR38505</name>
      <address>
        <city>Zadar</city>
        <zip>23 000</zip>
        <country>Croatia</country>
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      <name>Site HR38501</name>
      <address>
        <city>Zagreb</city>
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        <country>Croatia</country>
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  </location>
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    <facility>
      <name>Site CZ42002</name>
      <address>
        <city>Brno-Bohunice</city>
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        <country>Czechia</country>
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      <name>Site CZ42005</name>
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        <city>Kyjov</city>
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        <country>Czechia</country>
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      <name>Site CZ42004</name>
      <address>
        <city>Opava</city>
        <zip>74601</zip>
        <country>Czechia</country>
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  </location>
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    <facility>
      <name>Site CZ42003</name>
      <address>
        <city>Praha 5</city>
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        <country>Czechia</country>
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      <name>Site FI35801</name>
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      <name>Site DE49011</name>
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        <city>Köln</city>
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      <name>Site DE49008</name>
      <address>
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      <name>Site GR30005</name>
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      <address>
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      <address>
        <city>Limerick</city>
        <zip>V94 F858</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39009</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39005</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</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 IT39003</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39007</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39002</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39001</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39006</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site IT39010</name>
      <address>
        <city>Torino</city>
        <zip>10154</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48012</name>
      <address>
        <city>Lodz</city>
        <state>PL</state>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48004</name>
      <address>
        <city>Gdynia</city>
        <zip>81-348</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48011</name>
      <address>
        <city>Szczecin</city>
        <zip>71-899</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48008</name>
      <address>
        <city>Warsaw</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48002</name>
      <address>
        <city>Warsaw</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL48003</name>
      <address>
        <city>Zgierz</city>
        <zip>95-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PT35101</name>
      <address>
        <city>Almada</city>
        <zip>2800-525</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PT35102</name>
      <address>
        <city>Amadora</city>
        <zip>2720-276</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PT35106</name>
      <address>
        <city>Cotter</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PT35104</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PT35107</name>
      <address>
        <city>Vila Real</city>
        <zip>5000-508</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RO40001</name>
      <address>
        <city>Bucharest</city>
        <zip>21105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RO40003</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400348</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RO40002</name>
      <address>
        <city>Lasi</city>
        <zip>700116</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RU70001</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site RU70003</name>
      <address>
        <city>Moscow</city>
        <zip>123423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SI38601</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SI38605</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SI38602</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SI38603</name>
      <address>
        <city>Murska Sobota</city>
        <zip>9000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34003</name>
      <address>
        <city>Barakaldo, Vizcaya</city>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34004</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34005</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34006</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SE46002</name>
      <address>
        <city>Göteborg</city>
        <zip>41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SE46004</name>
      <address>
        <city>Jönköping</city>
        <zip>55185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SE46001</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site SE46005</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CH41001</name>
      <address>
        <city>Lugano</city>
        <state>Ticino</state>
        <zip>CH-6903</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CH41002</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CH41004</name>
      <address>
        <city>Zürich</city>
        <zip>8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90003</name>
      <address>
        <city>Adana</city>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90002</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90007</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90001</name>
      <address>
        <city>Antalya</city>
        <zip>07059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90006</name>
      <address>
        <city>Eskisehir</city>
        <zip>26480</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90005</name>
      <address>
        <city>Istanbul</city>
        <zip>34662</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site TR90004</name>
      <address>
        <city>Istanbul</city>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44003</name>
      <address>
        <city>Sutton in Ashfield</city>
        <state>Nottinghamshire</state>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44006</name>
      <address>
        <city>Bristol</city>
        <state>UK</state>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44008</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44005</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44010</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44009</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Norway</country>
  </removed_countries>
  <link>
    <url>https://www.astellasclinicalstudyresults.com/patientStudySearch.aspx?RID=;;;2819-MA-1002</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Fidaxomicin</keyword>
  <keyword>Clostridium Difficile</keyword>
  <keyword>Vancomycin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</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 trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. 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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02254967
org study id: 2819-MA-1002
secondary id: 2013-004619-31
nct id: NCT02254967
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to evaluate whether the extended duration fidaxomicin
      therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at
      30 days after end of treatment (Day 40 or Day 55).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
time frame: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
description: Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
measure: Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
time frame: Day 40, 55, 90
description: Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the ESCMID criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
measure: Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
time frame: Day 12, 27
description: Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.
measure: Percentage of Participants with a Clinical Response of CDI at Day 12
time frame: Day 12
description: Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.
measure: Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
time frame: Baseline through day 90
description: For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).
measure: Time to Resolution of Diarrhea (TTROD)
time frame: Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
description: Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, > 50% reduction in number of stools or > 75% reduction in volume of liquid stool) that are sustained through to TOC.
measure: Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
time frame: Day 40, 55, 90
description: For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.
measure: Time to Recurrence of CDI after End of Active Treatment
time frame: From day 10 up to day 90
description: Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.
measure: Disease-free Survival After Day 10
time frame: From day 10 up to day 90
description: Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.
arm group label: Fidaxomicin Extended Pulsed Regimen (EPFX)
arm group type: Experimental
description: Participants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.
arm group label: Vancomycin
arm group type: Experimental
description: Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.
intervention type: Drug
intervention name: Fidaxomicin
description: oral tablets administered in an extended pulsed regimen
arm group label: Fidaxomicin Extended Pulsed Regimen (EPFX)
other name: OPT-80
other name: ASP2819
other name: Dificlir
other name: Dificid
intervention type: Drug
intervention name: Vancomycin
description: oral capsule
arm group label: Vancomycin
other name: Vancocin
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Europe Ltd.
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country: Austria
country: Belgium
country: Croatia
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Hungary
country: Ireland
country: Italy
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Slovenia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: Czech Republic
country: Norway
url: https://www.astellasclinicalstudyresults.com/patientStudySearch.aspx?RID=;;;2819-MA-1002
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Vancomycin
mesh term: Fidaxomicin
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. 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/