NCT01591863View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 15, 2012

Primary Completion Date

March 7, 2014

Study Completion Date

March 7, 2014

Conditions
Clostridium Difficile-associated Diarrhea
Interventions
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."

All Listed Sponsors
lead

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

NCT01591863 - Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) | Biotech Hunter | Biotech Hunter