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

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: GIRCI Ile de France
• Treatments: Vancomycin

Criteria

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