<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/NCT03029078</url>
  </required_header>
  <id_info>
    <org_study_id>GIPIT002</org_study_id>
    <secondary_id>2014-003048-11</secondary_id>
    <nct_id>NCT03029078</nct_id>
  </id_info>
  <brief_title>FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?</brief_title>
  <acronym>FEDEX</acronym>
  <official_title>FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</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>
      Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug&#xD;
      Resistant (XDR) bacteria by performing a fecal transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main objective:&#xD;
&#xD;
      Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal&#xD;
      transplantation from a healthy donor.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy&#xD;
      of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or&#xD;
      carbapenem resistant enterobacteriae (CRE)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negativation of digestive tract colonization</measure>
    <time_frame>At one week, 2 weeks, one month up to 6 months</time_frame>
    <description>Negativation of the rectal swab performed, free from CRE or GRE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metagenomics profile between donor and recipient depending on decolonization</measure>
    <time_frame>At one week, 2 weeks, one month up to 3 months</time_frame>
    <description>Study with a universal super donor in order to improve efficacy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Microbial Colonization</condition>
  <condition>Bacterial Peritonitis</condition>
  <condition>Faeces Smearing</condition>
  <arm_group>
    <arm_group_label>Fecal transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study.&#xD;
Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant.&#xD;
Patient will be monitored for 24h to rule out potential adverse events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fecal microbiota transplant</intervention_name>
    <description>We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract</description>
    <arm_group_label>Fecal transplantation</arm_group_label>
    <other_name>FEDEX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient harboring a VRE or CRE bacteria&#xD;
&#xD;
          -  Colonization confirmed by our microbiology department, including at least 3 positives&#xD;
             swabs in the last month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman or breastfeeding&#xD;
&#xD;
          -  immunosuppression including AIDS, corticosteroids over 60mg/day&#xD;
&#xD;
          -  ongoing antibiotic treatment at the day of inclusion&#xD;
&#xD;
          -  impossibility to obtain a signed consent form.&#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>Benjamin Davido, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.omedit-centre.fr/portail/gallery_files/site/136/2953/4197/4829/5484/5489.pdf</url>
    <description>cited in slide #30</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre d'Investigation Clinique et Technologique 805</investigator_affiliation>
    <investigator_full_name>Benjamin DAVIDO</investigator_full_name>
    <investigator_title>M.D, M.S</investigator_title>
  </responsible_party>
  <keyword>XDR</keyword>
  <keyword>fecal microbiota transplant</keyword>
  <keyword>eradicate</keyword>
  <keyword>colonization</keyword>
  <keyword>CRE</keyword>
  <keyword>GRE</keyword>
  <keyword>bacteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-003048-11/FR</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03029078
org study id: GIPIT002
secondary id: 2014-003048-11
nct id: NCT03029078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug
      Resistant (XDR) bacteria by performing a fecal transplantation.
Main objective:

      Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal
      transplantation from a healthy donor.

      Secondary objectives:

      English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy
      of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or
      carbapenem resistant enterobacteriae (CRE)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization
primary purpose: Treatment
masking: None (Open Label)
measure: Negativation of digestive tract colonization
time frame: At one week, 2 weeks, one month up to 6 months
description: Negativation of the rectal swab performed, free from CRE or GRE
measure: Metagenomics profile between donor and recipient depending on decolonization
time frame: At one week, 2 weeks, one month up to 3 months
description: Study with a universal super donor in order to improve efficacy
arm group label: Fecal transplantation
arm group type: Experimental
description: Patient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study.
Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant.
Patient will be monitored for 24h to rule out potential adverse events.
intervention type: Drug
intervention name: fecal microbiota transplant
description: We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
arm group label: Fecal transplantation
other name: FEDEX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Davido, MD, MS
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
url: http://www.omedit-centre.fr/portail/gallery_files/site/136/2953/4197/4829/5484/5489.pdf
description: cited in slide #30
responsible party type: Principal Investigator
investigator affiliation: Centre d'Investigation Clinique et Technologique 805
investigator full name: Benjamin DAVIDO
investigator title: M.D, M.S
mesh term: Peritonitis
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No
study doc: 