Fecal transplantation to Eradicate Colonizing Emergent Superbugs

Phase 1

• Conditions: Patients colonized with MDR-GNB (multi-drug resistant Gram Negative bacteria ); MedDRA version: 20.1Level: LLTClassification code 10028152Term: Multi-antibiotic resistanceSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-004402-10-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

a) Donors:
- Healthy subjects =18 years and < 50 years
- Subjects acceptable for stool donation according to the published recommendations for clinical and microbiological screening of the subject and of the stool of the Agence nationale de sécurité du médicament et des produits de santé (ANSM) in 2016.
- Written informed consent

b) Patients:
- =18 years and <105 years
- Colonized with a carbapenem-resistant Enterobacteriaceae (CRE) at inclusion on stool culture, or colonized with ESBL-E at inclusion on stool culture AND having suffered from an infection with an ESBL-E in the previous 12 months
- Capable of taking oral capsules (n=25 two days in a row) with no dysphagia or swallowing disorders.
- Written informed consent

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 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

Exclusion Criteria

a)Donors:
- Any history of, or current proctologic disease, or any acute condition, which in the investigator’s judgment could harm the volunteer and / or compromise or limit the evaluation of the protocol or data analysis (cf. protocole).
- Non-affiliation to a social security scheme (AME excepted)

b) Patients:
- Antibiotic treatment on the day of inclusion except for long term antibiotic prophylaxis (for at least 3 months/year)
- Patients hospitalized in the intensive care unit
- Pregnancy or breastfeeding during the study (see definitions in annex 5)
- Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study
- Patient under legal guardianship
- Participation in another trial
- Non-affiliation to a social security scheme (AME excepted)
NB. If an antibiotic treatment can be anticipated (for ex. prophylaxis treatment for surgery, or expected neutropenia) inclusion should be delayed to limit the use of antibiotics just after FMT.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified