Patient harboring Extreme Drug Resistant (XDR) bacteria. Our trial try to eradicate this digestive tract colonization by performing a fecal transplantation.
Conditions
Interventions
Product Name: Fecal Transplant (feces)
Pharmaceutical Form: Oral/rectal solution
Sponsors
GIPIT
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Evaluate side effects of this procedure including digestive signs such as nausea, abdominal pain. Evaluate predictable factors of failure of this procedure. 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. Evaluate predictable factors of failure of this procedure. Evaluate efficacy of fecal transplant if the patient is harboring GRE or CRE | — |
Countries
France
Contacts
Public ContactPierre de Truchis (Trésorier)
GIPIT (Groupe d’Investigation en Pathologies Infectieuses et Tropicales)
Outcome results
None listed