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A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

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Trial Profile

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Fidaxomicin (Primary) ; Vancomycin
  • Indications Clostridium difficile infections; Diarrhoea
  • Focus Registrational; Therapeutic Use
  • Acronyms SUNSHINE
  • Sponsors Astellas Pharma Europe Ltd

Most Recent Events

  • 27 Jan 2020 According to a Merck & Co media release, the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older and both applications received a priority review classification by the FDA.
  • 27 Nov 2019 Primary endpoint has not been met. (Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days)
  • 27 Nov 2019 Results published in the Clinical Infectious Diseases

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