A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) — SUNSHINE

Clostridium Difficile-associated Diarrhea (CDAD) Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clostridium Difficile-associated Diarrhea (CDAD)
Clostridium Infections
Diarrhea

Clinical Trial Details

NCT number	NCT02218372
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Completed
Phase	Phase 3
Start date	January 9, 2015
Completion date	March 7, 2018

View Details

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT00177970` - IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff	Phase 4
	Completed	`NCT01691248` - Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)	Phase 3