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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 03 May 2017

At a glance

  • Drugs Fidaxomicin (Primary)
  • Indications Clostridium infections; Diarrhoea
  • Focus Registrational; Therapeutic Use
  • Acronyms DEFLECT-1
  • Sponsors Merck Sharp & Dohme; Optimer Pharmaceuticals
  • Most Recent Events

    • 08 Dec 2015 Results of subgroup analysis presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
    • 27 Apr 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 15 Jan 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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