Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant: a Double-blind Placebo-controlled Randomized Clinical Trial

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 vancomycine reducing the risk of CD infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.

Inclusion Criteria:

• 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 Criteria:

• 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