At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
fidaxomicindrug
Likely dose
fidaxomicin 32 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted May 4, 2012·Updated Sep 18, 2018
In Brief
A Phase 2 clinical trial evaluating fidaxomicin for Clostridium Difficile-associated Diarrhea. Completed, enrolled 38 participants.
Detailed Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2012
Primary CompletionMar 2014
TodayJul 2026
First PostedMay 4, 2012
Enrollment StartJun 15, 2012
Primary CompletionMar 7, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.2 years ago
Interventions
fidaxomicindrug
6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.