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

Primary Purpose

Microbial Colonization, Bacterial Peritonitis, Faeces Smearing

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
fecal microbiota transplant
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbial Colonization focused on measuring XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Raymond Poincaré

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal transplantation

Arm 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.

Outcomes

Primary Outcome Measures

Negativation of digestive tract colonization
Negativation of the rectal swab performed, free from CRE or GRE

Secondary Outcome Measures

Metagenomics profile between donor and recipient depending on decolonization
Study with a universal super donor in order to improve efficacy

Full Information

First Posted
January 20, 2017
Last Updated
July 26, 2021
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT03029078
Brief Title
FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
Acronym
FEDEX
Official Title
FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Bacterial Peritonitis, Faeces Smearing
Keywords
XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal transplantation
Arm Type
Experimental
Arm 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(s)
fecal microbiota transplant
Other Intervention Name(s)
FEDEX
Intervention Description
We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
Primary Outcome Measure Information:
Title
Negativation of digestive tract colonization
Description
Negativation of the rectal swab performed, free from CRE or GRE
Time Frame
At one week, 2 weeks, one month up to 6 months
Secondary Outcome Measure Information:
Title
Metagenomics profile between donor and recipient depending on decolonization
Description
Study with a universal super donor in order to improve efficacy
Time Frame
At one week, 2 weeks, one month up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Davido, MD, MS
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.omedit-centre.fr/portail/gallery_files/site/136/2953/4197/4829/5484/5489.pdf
Description
cited in slide #30
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-003048-11/FR

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

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