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)

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).

Inclusion Criteria:

• Male or female 6 months to 17 years 11 months of age, inclusive;
• Female subjects of childbearing potential must use adequate contraception
• Diagnosed with CDAD

Exclusion Criteria:

• Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
• Fulminant colitis
• History of inflammatory bowel disease
• Pregnant or breast-feeding
• Need for concurrent use of some P-glycoprotein inhibitors during therapy