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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
EU CTIS ID: 2024-513490-45-00
What this study is testing
Evaluate the effectiveness of primary prophylaxis with oral vancomycin on the prevention of Clostridium difficile infections in patients hospitalized for allogeneic HCT transplantation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
See the full eligibility criteria
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.