CompletedPhase 2

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

38 participantsStarted 2012-06-15

Plain-language 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).

Who can participate

Age range6 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Adverse Events.

Timeframe: Enrollment through end of study (Day 38-41)

Investigate Concentrations of Fidaxomicin in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of Fidaxomicin in Fecal Samples.

Timeframe: End of Therapy; Day 10-11

Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.

Timeframe: End of Therapy; Day 10-11

Trial details

NCT IDNCT01591863

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03-07

Results submitted2015-03-05

View on ClinicalTrials.gov More Clostridium Difficile-associated Diarrhea trials