Clinical trial • Phase III • Infectious Disease
ALLOGENEIC FAECAL MICROBIOTA, POOLED for Colonization with multidrug-resistant Gram-negative bacteria (MDR-GNB) | Multi-antibiotic resistance
Phase III trial of ALLOGENEIC FAECAL MICROBIOTA, POOLED for Colonization with multidrug-resistant Gram-negative bacteria (MDR-GNB) | Multi-antibiotic resi…
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Colonization with multidrug-resistant Gram-negative bacteria (MDR-GNB) | Multi-antibiotic resistance
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 08-10-2024
- First CTIS Authorization Date
- 03-12-2024
Trial design
Randomised, test arm: double encapsulated oral transplant of fecal microbiota (active substance: allogeneic faecal microbiota, pooled), oral. comparator/placebo arm: placebo double encapsulated oral transplant of fecal microbiota (placebo, nacl; active substance: placebo), oral. reported product-level dosing metadata: max daily dose 16250 µl; max total dose 32500 µl; max treatment period 2 (time unit code 1). (no detailed schedule/dose escalation scheme explicitly provided in the record.)-controlled Phase III trial across 11 sites in France.
- Randomised
- Yes
- Comparator
- Test arm: Double encapsulated oral transplant of fecal microbiota (active substance: ALLOGENEIC FAECAL MICROBIOTA, POOLED), oral. Comparator/placebo arm: Placebo double encapsulated oral transplant of fecal microbiota (Placebo, NaCl; active substance: PLACEBO), oral. Reported product-level dosing metadata: max daily dose 16250 µl; max total dose 32500 µl; max treatment period 2 (time unit code 1). (No detailed schedule/dose escalation scheme explicitly provided in the record.)
- Target Sample Size
- 299
Eligibility
Recruits 299 Vulnerable population not selected (isVulnerablePopulationSelected: false). Specific exclusions apply for persons under legal protection and subjects under AME (listed in exclusion criteria). Informed consent materials for adult participants and adult donors are provided (documents: "L1_SIS and ICF adult patient" and "L1_SIS and ICF adult donor"). No assent or minor consent procedures are indicated in the record..
- Pregnancy Exclusion
- Patient: Pregnancy or breastfeeding during the study
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected: false). Specific exclusions apply for persons under legal protection and subjects under AME (listed in exclusion criteria). Informed consent materials for adult participants and adult donors are provided (documents: "L1_SIS and ICF adult patient" and "L1_SIS and ICF adult donor"). No assent or minor consent procedures are indicated in the record.
Inclusion criteria
- {"criterion_text":"- Patient: ≥ 18 years and < 105 years\n- 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\n- Patient: Patient able to take 50 capsules orally in a day and without swallowing disorders\n- Donor: Healthy subjects ≥ 18 years and < 50 years\n- Donor: Body mass index <30 kg/m2\n- Donor: Regular bowel movement defined as at least 1 stool every 2 days and maximum than 3 stools per day\n- Donor: See protocol for details of clinical and biological criteria"}
Exclusion criteria
- {"criterion_text":"- Patient: Current antibiotic treatment with the exception of long term antibiotic prophylaxis (duration of at least 3 months/year)\n- Patient: Patient under legal protection\n- Patient: Participation in another interventional study\n- Patient: No-affiliation to a social security scheme\n- Patient: Refusal to participate to the study\n- 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\n- Donor : Subject under AME\n- Patient : Patient under AME\n- Donor: Subject under legal protection\n- Donor: Participation in any other interventional study\n- Donor: No-affiliation to a social security scheme\n- Donor: Refusal to participate to the study\n- Donor: See protocol for details of clinical and biological criteria\n- Patients: Patients hospitalized in the intensive care unit\n- Patient: Pregnancy or breastfeeding during the study\n- 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"As determined by culture methods at 30 ± 10 days after randomization"}
Recruitment
- Planned Sample Size
- 299
- Recruitment Window Months
- 63
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms available for adult patients and adult donors (documents listed: "L1_SIS and ICF adult patient", "L1_SIS and ICF adult donor"). No assent for minors is indicated; minors are excluded by age criteria (≥18 years).
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 299
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 09-05-2025
- Processing Time Days
- 207
- Number Of Sites
- 11
- Number Of Participants
- 299
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious disease intervention unit
- Principal Investigator Name
- Anne-Lise MUNIER
- Principal Investigator Email
- anne-lise.munier@aphp.fr
- Contact Person Name
- Anne-Lise MUNIER
- Contact Person Email
- anne-lise.munier@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Matthieu LAFAURIE
- Principal Investigator Email
- matthieu.lafaurie@aphp.fr
- Contact Person Name
- Matthieu LAFAURIE
- Contact Person Email
- matthieu.lafaurie@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Alexandre BLEIBTREU
- Principal Investigator Email
- alexandre.bleibtreu@aphp.fr
- Contact Person Name
- Alexandre BLEIBTREU
- Contact Person Email
- alexandre.bleibtreu@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Transversal Infection Treatment
- Principal Investigator Name
- Raphaël LEPEULE
- Principal Investigator Email
- raphael.lepeule@aphp.fr
- Contact Person Name
- Raphaël LEPEULE
- Contact Person Email
- raphael.lepeule@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious disease
- Principal Investigator Name
- Ruxandra CALIN
- Principal Investigator Email
- ruxandra.calin@aphp.fr
- Contact Person Name
- Ruxandra CALIN
- Contact Person Email
- ruxandra.calin@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Specialized Acute Medicine
- Principal Investigator Name
- Benjamin DAVIDO
- Principal Investigator Email
- benjamin.davido@aphp.fr
- Contact Person Name
- Benjamin DAVIDO
- Contact Person Email
- benjamin.davido@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Laure SURGERS
- Principal Investigator Email
- laure.surgers@aphp.fr
- Contact Person Name
- Laure SURGERS
- Contact Person Email
- laure.surgers@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Clinical Investigation Center
- Principal Investigator Name
- Xavier DUVAL
- Principal Investigator Email
- xavier.duval@aphp.fr
- Contact Person Name
- Xavier DUVAL
- Contact Person Email
- xavier.duval@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Internal Medicine
- Principal Investigator Name
- Victoire DE LASTOURS
- Principal Investigator Email
- victoire.de-lastours@aphp.fr
- Contact Person Name
- Victoire DE LASTOURS
- Contact Person Email
- victoire.de-lastours@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Internal medicine and infectious disease
- Principal Investigator Name
- Lélia ESCAUT
- Principal Investigator Email
- lelia.escaut@aphp.fr
- Contact Person Name
- Lélia ESCAUT
- Contact Person Email
- lelia.escaut@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Prevention of Infectious Risk
- Principal Investigator Name
- Solen KERNEIS
- Principal Investigator Email
- solen.kerneis@aphp.fr
- Contact Person Name
- Solen KERNEIS
- Contact Person Email
- solen.kerneis@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Double encapsulated oral transplant of fecal microbiota
- Active Substance
- ALLOGENEIC FAECAL MICROBIOTA, POOLED
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 32500 µl
- Investigational Product Name
- Placebo double encapsulated oral transplant of fecal microbiota
- Active Substance
- PLACEBO
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 32500 µl
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