Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top