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

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

Official Title
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A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Conditions
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Clostridium Difficile-associated Diarrhea

Intervention / Treatment
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* Drug: fidaxomicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fidaxomicin<br> | Drug: fidaxomicin<br>* 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.<br>* Other names: PAR-101;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile-associated diarrhea, CDAD, Pediatric