clinical trial · NCT02218372
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)
Astellas Pharma Europe B.V.·phase3·completed·n = 148
Clostridium Difficile-associated Diarrhea (CDAD)Fidaxomicin oral suspensionFidaxomicin tabletsVancomycin oral liquidVancomycin capsules
brief 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.
started
Jan 9, 2015
primary completion
Mar 7, 2018
completion
Mar 7, 2018
last updated
Nov 26, 2024
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol