Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria? (FEDEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03029078
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin DAVIDO, Centre d'Investigation Clinique et Technologique 805

Brief Summary:
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.

Condition or disease Intervention/treatment Phase
Microbial Colonization Bacterial Peritonitis Faeces Smearing Drug: fecal microbiota transplant Phase 4

Detailed Description:

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal transplantation

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.

Drug: fecal microbiota transplant
We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
Other Name: FEDEX




Primary Outcome Measures :
  1. Negativation of digestive tract colonization [ Time Frame: At one week, 2 weeks, one month up to 6 months ]
    Negativation of the rectal swab performed, free from CRE or GRE


Secondary Outcome Measures :
  1. Metagenomics profile between donor and recipient depending on decolonization [ Time Frame: At one week, 2 weeks, one month up to 3 months ]
    Study with a universal super donor in order to improve efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient harboring a VRE or CRE bacteria
  • Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month

Exclusion Criteria:

  • Pregnant woman or breastfeeding
  • immunosuppression including AIDS, corticosteroids over 60mg/day
  • ongoing antibiotic treatment at the day of inclusion
  • impossibility to obtain a signed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029078


Contacts
Layout table for location contacts
Contact: Benjamin Davido, MD, MS +33147107758 benjamin.davido@aphp.fr
Contact: Aurélien Dinh, MD +33147107774 aurelien.dinh@aphp.fr

Locations
Layout table for location information
France
Hopital Raymond Poincaré Recruiting
Garches, France, 92380
Contact: Benjamin Davido, MD; MS    +33147107758    benjamin.davido@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Layout table for investigator information
Principal Investigator: Benjamin Davido, MD, MS Assistance Publique - Hôpitaux de Paris

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Benjamin DAVIDO, M.D, M.S, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03029078     History of Changes
Other Study ID Numbers: GIPIT002
2014-003048-11 ( EudraCT Number )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin DAVIDO, Centre d'Investigation Clinique et Technologique 805:
XDR
fecal microbiota transplant
eradicate
colonization
CRE
GRE
bacteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritonitis
Communicable Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases