FEcal transplant, a hope to Eradicate colonization of patient harboring eXtreme drug resistantbacteria?

Active, not recruiting

Conditions: Patient harboring Extreme Drug Resistant (XDR) bacteria. Our trial try to eradicate this digestive tract colonization by performing a fecal transplantation.
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-003048-11-FR

Lead Sponsor: GIPIT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patient aged over 18, harboring a GRE or CRE bacteria confirmed by our microbiology department (on 3 swabs performed every week during 3 weeks).
Patient agreed and signed the consent form.
Donor feces must be indemn of bacterial, viral or fungal infection (tested on feces or serology)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.;Secondary Objective: Evaluate the side effects of this procedure and tolerability.<br>Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE);Primary end point(s): Negativation of the rectal swab performed.;Timepoint(s) of evaluation of this end point: Rectal swab will be performed at one week, 2 weeks, one month up to six months in order to assess the negativation of the XDR bacteria.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Evaluate side effects of this procedure including digestive signs such as nausea, abdominal pain.<br>Evaluate predictable factors of failure of this procedure.<br>Evaluate efficacy of fecal transplant if the patient is harboring GRE or CRE;Secondary end point(s): Evaluate side effects of this procedure including digestive signs such as nausea, abdominal pain.<br>Evaluate predictable factors of failure of this procedure.<br>Evaluate efficacy of fecal transplant if the patient is harboring GRE or CRE