Status:
UNKNOWN
Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
GIRCI Ile de France
Conditions:
Clostridium Difficile Infections
Stem Cell Transplant Complications
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
Clostridium difficile (CD) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The VANCALLO trial aims at evaluating oral v...
Eligibility Criteria
Inclusion
- Age ≥15 ans
- Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning
- For men and women of reproductive age: use of contraceptives
- Informed consent
- Healthcare insurance
Exclusion
- Know allergy or history of adverse events with vancomycine
- Pregnancy
- Clostridium difficile infection within 30 days prior to inclusion or at inclusion
- History of total colectomy and/or inflammatory bowel disease
- Progressive diarrhea at inclusion, whichever the etiology
- Digestive decontamination protocol for the stem cell transplant procedure
- Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT05256693
Start Date
March 1 2022
End Date
July 1 2025
Last Update
February 25 2022
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