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Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) — DEFLECT-1  

Clostridium Difficile-Associated Diarrhea (CDAD) Clinical Trial

Official title:
DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Summary

The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Clostridium Difficile-Associated Diarrhea (CDAD)
  • Diarrhea
Clinical Trial Details
NCT number NCT01691248
Study type Interventional
Source Optimer Pharmaceuticals LLC
Contact
Status Completed
Phase Phase 3
Start date October 10, 2012
Completion date April 16, 2015
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00177970 - IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff Phase 4
Completed NCT02218372 - A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) Phase 3