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

• Status: Completed
• Trial end date: 2014-03-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Optimer Pharmaceuticals LLC
• Treatments: Fidaxomicin

Criteria

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