NCT01591863

Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Clostridium Difficile-associated Diarrhea

Interventions

Type	Name	Description
DRUG	fidaxomicin	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.

Timeline

• Start date: 2012-06-15
• Primary completion: 2014-03-07
• Completion: 2014-03-07
• First posted: 2012-05-04
• Last updated: 2018-09-18
• Results posted: 2015-03-17