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

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

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile-associated Diarrhea

Treatments: Drug: fidaxomicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591863

OPT-80-206 (Other Identifier)

5119-010

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

fidaxomicin

Experimental group

Treatment:

Drug: fidaxomicin