Conditions: Clostridium Difficile-associated Diarrhea
Keywords: Clostridium difficile-associated diarrhea CDAD Pediatric
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: fidaxomicin
Intervention descriptions: intervention 1: 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.

Protocol document: