VANCALLO - Prevention of C. difficile infections by oral vancomycin in patients treated for allogeneic hematopoietic stem cell transplantation, a randomized double-blind placebo-controlled trial
- Conditions
- Patients hospitalized for allogeneic hematopoietic stem cell transplantationMedDRA version: 20.0Level: PTClassification code: 10054236Term: Clostridium difficile infection Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2024-513490-45-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
Age =15 years, - Patient hospitalized for less than 72 hours to receive an allograft of HSC, whatever the indication and packaging,, - for men and women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout the Research and up to 1 month after the end of treatment (see point 6.1 Inclusion criteria), - Have given consent for participation in the study., - Beneficiary of health insurance
- Documented allergy or adverse reactions to vancomycin, - Pregnancy and breast feeding, - Clostridium difficile infection within 30 days preceding inclusion or on the day of inclusion, - History of total colectomy and/or chronic inflammatory bowel disease, - Progressive diarrhea at inclusion regardless of the etiology, - Digestive decontamination protocol during the transplant procedure, - Participation in another medicinal intervention research involving humans or being in the exclusion period following previous research involving humans, if applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method