Overview

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)

Status:
Completed

Trial end date:
2018-03-07

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Astellas Pharma Europe B.V.

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Fidaxomicin
Vancomycin