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 - APHP210089

Assistance Publique Hopitaux De Paris0 个研究点目标入组 336 人开始时间: 2024年5月14日最近更新: 2024年7月22日

适应症

试验速览

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•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

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