<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/NCT03760484</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00081229</org_study_id>
    <nct_id>NCT03760484</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection</brief_title>
  <official_title>Serial Fecal Microbiota Transplant (FMT) Plus Fidaxomicin in the Treatment of Severe or Fulminant Clostridium Difficile Infection, With Detailed Characterization in Microbiota, Metabolomics and Host Immune Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from&#xD;
      mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in&#xD;
      treating severe and fulminant CDI. Current evidence suggests that FMT in combination with&#xD;
      vancomycin is required, and that multiple treatments are necessary. The investigators think&#xD;
      fidaxomicin may be a better option in the context and may potentially reduce the number of&#xD;
      FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In&#xD;
      this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to&#xD;
      determine efficacy and safety in treating patients with severe or fulminant CDI. The&#xD;
      investigators want to see if this approach may reduce the number of FMT treatment required,&#xD;
      and/or the length of hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective, open -label, multi--center feasibility study, the investigators aim to&#xD;
      determine the efficacy and safety of using combined serial FMT by enema plus fidaxomicin to&#xD;
      treat patients who have severe or fulminant CDI not responding to maximal medical therapy.&#xD;
      The hypothesis is the combination of FMT plus fidaxomicin can reduce the number of FMT&#xD;
      required and/or hospital length of stay compared to FMT plus vancomycin.&#xD;
&#xD;
      Participants will receive FMT by enemas over 3 days which constitutes a single cycle with&#xD;
      concurrent treatment with oral fidaxomicin. If participants do not show improvement&#xD;
      biochemically or clinically, then a repeat FMT cycle will be administered to a maximum of 4&#xD;
      cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty enrolling participants/COVID pandemic/lack of continued in-kind support from product&#xD;
    manufacturer.&#xD;
  </why_stopped>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))</measure>
    <time_frame>2 weeks after final Fecal Microbiota Transplant (FMT)</time_frame>
    <description>Defined as &lt;3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT)</time_frame>
    <description>Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days</time_frame>
    <description>Reported death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perforation</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days</time_frame>
    <description>Colonic perforation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
    <description>Proven infection related final Fecal Microbiota Transplant (FMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
    <description>Hospitalization due to C. difficile infection (CDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colectomy</measure>
    <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
    <description>Surgical Intervention - Colectomy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Clostridium Difficile</condition>
  <arm_group>
    <arm_group_label>fecal transplant with fidaxomicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fidaxomicin 200 mg</intervention_name>
    <description>Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.</description>
    <arm_group_label>fecal transplant with fidaxomicin</arm_group_label>
    <other_name>dificid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>fecal microbiota transplantation (FMT)</intervention_name>
    <description>Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
    <arm_group_label>fecal transplant with fidaxomicin</arm_group_label>
    <other_name>biotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years with severe1 or fulminant2 CDI, without an adequate response to&#xD;
             metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after&#xD;
             Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in&#xD;
             stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48&#xD;
             hours&#xD;
&#xD;
          -  Those with ability to provide informed consent or an alternative decision maker&#xD;
             providing assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with bowel perforation&#xD;
&#xD;
          -  Those taking chemotherapy or radiation treatment with absolute neutrophil count of &lt;&#xD;
             1000 cells/mm3&#xD;
&#xD;
          -  Those with known colonic strictures&#xD;
&#xD;
          -  Those with subtotal colectomy or planning to have a colectomy&#xD;
&#xD;
          -  Those with significant ileus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Kao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Monaghan TM, Duggal NA, Rosati E, Griffin R, Hughes J, Roach B, Yang DY, Wang C, Wong K, Saxinger L, Pucic-Bakovic M, Vuckovic F, Klicek F, Lauc G, Tighe P, Mullish BH, Blanco JM, McDonald JAK, Marchesi JR, Xue N, Dottorini T, Acharjee A, Franke A, Li Y, Wong GK, Polytarchou C, Yau TO, Christodoulou N, Hatziapostolou M, Wang M, Russell LA, Kao DH. A Multi-Factorial Observational Study on Sequential Fecal Microbiota Transplant in Patients with Medically Refractory Clostridioides difficile Infection. Cells. 2021 Nov 19;10(11):3234. doi: 10.3390/cells10113234.</citation>
    <PMID>34831456</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>September 14, 2022</results_first_submitted>
  <results_first_submitted_qc>November 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 13, 2022</results_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fecal microbiota transplantation</keyword>
  <keyword>Fidaxomicin</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>Fidaxomicin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>April 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03760484/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03760484/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fecal Transplant With Fidaxomicin</title>
          <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fecal Transplant With Fidaxomicin</title>
          <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80+ years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))</title>
        <description>Defined as &lt;3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)</description>
        <time_frame>2 weeks after final Fecal Microbiota Transplant (FMT)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))</title>
          <description>Defined as &lt;3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))</title>
        <description>Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))</title>
          <description>Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death</title>
        <description>Reported death</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Death</title>
          <description>Reported death</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perforation</title>
        <description>Colonic perforation</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Perforation</title>
          <description>Colonic perforation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infection</title>
        <description>Proven infection related final Fecal Microbiota Transplant (FMT)</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Infection</title>
          <description>Proven infection related final Fecal Microbiota Transplant (FMT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization</title>
        <description>Hospitalization due to C. difficile infection (CDI)</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization</title>
          <description>Hospitalization due to C. difficile infection (CDI)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Colectomy</title>
        <description>Surgical Intervention - Colectomy</description>
        <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fecal Transplant With Fidaxomicin</title>
            <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Colectomy</title>
          <description>Surgical Intervention - Colectomy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fecal Transplant With Fidaxomicin</title>
          <description>FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days&#xD;
Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.&#xD;
Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Dina Kao</name_or_title>
      <organization>University of Alberta</organization>
      <phone>780-233-6025</phone>
      <email>dina.kao@ualberta.ca</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/NCT03760484
org study id: Pro00081229
nct id: NCT03760484
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from
      mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in
      treating severe and fulminant CDI. Current evidence suggests that FMT in combination with
      vancomycin is required, and that multiple treatments are necessary. The investigators think
      fidaxomicin may be a better option in the context and may potentially reduce the number of
      FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In
      this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to
      determine efficacy and safety in treating patients with severe or fulminant CDI. The
      investigators want to see if this approach may reduce the number of FMT treatment required,
      and/or the length of hospital stay.
In this prospective, open -label, multi--center feasibility study, the investigators aim to
      determine the efficacy and safety of using combined serial FMT by enema plus fidaxomicin to
      treat patients who have severe or fulminant CDI not responding to maximal medical therapy.
      The hypothesis is the combination of FMT plus fidaxomicin can reduce the number of FMT
      required and/or hospital length of stay compared to FMT plus vancomycin.

      Participants will receive FMT by enemas over 3 days which constitutes a single cycle with
      concurrent treatment with oral fidaxomicin. If participants do not show improvement
      biochemically or clinically, then a repeat FMT cycle will be administered to a maximum of 4
      cycles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))
time frame: 2 weeks after final Fecal Microbiota Transplant (FMT)
description: Defined as <3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)
measure: Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT)
description: Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)
measure: Death
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
description: Reported death
measure: Perforation
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
description: Colonic perforation
measure: Infection
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
description: Proven infection related final Fecal Microbiota Transplant (FMT)
measure: Hospitalization
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
description: Hospitalization due to C. difficile infection (CDI)
measure: Colectomy
time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
description: Surgical Intervention - Colectomy
arm group label: fecal transplant with fidaxomicin
arm group type: Experimental
description: FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days
intervention type: Drug
intervention name: Fidaxomicin 200 mg
description: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.
arm group label: fecal transplant with fidaxomicin
other name: dificid
intervention type: Biological
intervention name: fecal microbiota transplantation (FMT)
description: Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
arm group label: fecal transplant with fidaxomicin
other name: biotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dina Kao, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
citation: Monaghan TM, Duggal NA, Rosati E, Griffin R, Hughes J, Roach B, Yang DY, Wang C, Wong K, Saxinger L, Pucic-Bakovic M, Vuckovic F, Klicek F, Lauc G, Tighe P, Mullish BH, Blanco JM, McDonald JAK, Marchesi JR, Xue N, Dottorini T, Acharjee A, Franke A, Li Y, Wong GK, Polytarchou C, Yau TO, Christodoulou N, Hatziapostolou M, Wang M, Russell LA, Kao DH. A Multi-Factorial Observational Study on Sequential Fecal Microbiota Transplant in Patients with Medically Refractory Clostridioides difficile Infection. Cells. 2021 Nov 19;10(11):3234. doi: 10.3390/cells10113234.
PMID: 34831456
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Fidaxomicin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 