Fecal transplantation to Eradicate Colonizing Emergent Superbugs

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

3 Dec 2024 → ongoing

Decision date (initial)

2024-12-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516393-29-00

EudraCT number

2019-004402-10

ClinicalTrials.gov

NCT05035342

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Determine whether FMT with frozen capsules is effective for decolonization of MDR-GNB at 30±10 days post-randomization

Conditions and MedDRA coding

Patients colonized with MDR-GNB

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient: ≥ 18 years and < 105 years
2. Patient: Patient with at least one positive rectal swab for enterobacteria: extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory
3. Patient: Patient able to take 50 capsules orally in a day and without swallowing disorders
4. Donor: Healthy subjects ≥ 18 years and < 50 years
5. Donor: Body mass index <30 kg/m2
6. Donor: Regular bowel movement defined as at least 1 stool every 2 days and maximum than 3 stools per day
7. Donor: See protocol for details of clinical and biological criteria

Exclusion criteria 16

1. Patient: Current antibiotic treatment with the exception of long term antibiotic prophylaxis (duration of at least 3 months/year)
2. Donor: Subject under legal protection
3. Donor: Participation in any other interventional study
4. Donor: No-affiliation to a social security scheme
5. Donor: Refusal to participate to the study
6. Donor: See protocol for details of clinical and biological criteria
7. Patients: Patients hospitalized in the intensive care unit
8. Patient: Pregnancy or breastfeeding during the study
9. Patient: 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
10. Patient: Patient under legal protection
11. Patient: Participation in another interventional study
12. Patient: No-affiliation to a social security scheme
13. Patient: Refusal to participate to the study
14. Donor: 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
15. Donor : Subject under AME
16. Patient : Patient under AME

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects not carrying MDR-GNB (neither carbapenem-resistant Enterobacteriaceae [CRE] nor extended spectrum β-lactamase producing Enterobacteriaceae [ESBL-E]) at 30 ± 10 days after randomization, as determined by culture methods

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating Investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating Investigator

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications