NCT05256693

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile Infections
• Stem Cell Transplant Complications

Interventions

Type	Name	Description
DRUG	Vancomycin	Oral vancomycin (powder) 125mg twice a day
DRUG	Placebo	Vancomycine placebo (powder) twice a day

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-06-01
• Completion: 2025-07-01
• First posted: 2022-02-25
• Last updated: 2022-02-25