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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

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

    • 11 Aug 2017 Planned End Date changed from 10 Jan 2018 to 1 Jan 2018.
    • 11 Aug 2017 Planned primary completion date changed from 11 Dec 2017 to 1 Dec 2017.
    • 20 Apr 2017 Planned End Date changed from 1 Jul 2017 to 10 Jan 2018.
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