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

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.

本研究旨在探究难辨梭状芽孢杆菌相关性腹泻（Clostridium difficile-associated diarrhea, CDAD）儿科受试者，采用非达霉素（fidaxomicin）口服混悬剂或片剂、万古霉素（vancomycin）口服溶液剂或胶囊剂的临床应答效果。同时，本研究还考察了非达霉素与万古霉素的复发/持续临床应答情况及安全性，并评估了非达霉素口服混悬剂制剂的用药接受度。