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