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: 09 Jun 2018

At a glance

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

    • 09 Jun 2018 Primary endpoint has not been met. (The occurrence of CDAD from start of study treatment up to 30 days post-treatment follow-up in HSCT subjects)
    • 09 Jun 2018 Results published in the Clinical Infectious Diseases
    • 08 Dec 2015 Results of subgroup analysis presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top