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

Phase 2

Completed

• Conditions: Clostridium Difficile-associated Diarrhea
• Interventions: Drug: fidaxomicin

• Registration Number: NCT01591863
• Lead Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Study Start: 2012-06-15
• Primary Completion: 2014-03-07
• Study Completion: 2014-03-07
• Results First Submitted: 2015-03-05
• Results First Submitted QC: 2015-03-05
• Results First Posted: 2015-03-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fidaxomicin	fidaxomicin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events.	Enrollment through end of study (Day 38-41)	Number of participants with adverse events, as categorized by MedDRA.
Investigate Concentrations of Fidaxomicin in Plasma Samples.	3-5 hours after administration	3-5 hour plasma levels of fidaxomicin (mean)
Investigate Concentrations of Fidaxomicin in Fecal Samples.	End of Therapy; Day 10-11	End of therapy fecal levels of fidaxomicin (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.	3-5 hours after administration	3-5 hour plasma levels of OP-1118 (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.	End of Therapy; Day 10-11	End of therapy fecal levels of OP-1118 (mean)

Secondary Outcome Measures

Name	Time	Method
Evaluate the Clinical Outcome by Assessment of Clinical Response.	Day 10	Positive clinical response defined as resolution of diarrhea
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.	28 days post-treatment	Positive clinical response without recurrence through the follow-up period