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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2023

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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 Mar 2023 Results of pooled analysis of pharmacokinetic modeling study assessed whether hematopoietic stem cell transplant recipients, at increased risk of CDI and exhibiting decreased albumin levels within the first month posttransplant, are at risk of clinically relevant reductions in bezlotoxumab exposure from NCT01241552/NCT01513239, PN004, PN005, and PN006, NCT01777763 and NCT01691248 studies, published in the Clinical Therapeutics.
    • 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

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