The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
Number of Participants With Adverse Events.
Number of participants with adverse events, as categorized by MedDRA.
Time frame: Enrollment through end of study (Day 38-41)
Investigate Concentrations of Fidaxomicin in Plasma Samples.
3-5 hour plasma levels of fidaxomicin (mean)
Time frame: 3-5 hours after administration
Investigate Concentrations of Fidaxomicin in Fecal Samples.
End of therapy fecal levels of fidaxomicin (mean)
Time frame: 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)
Time frame: 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)
Time frame: End of Therapy; Day 10-11
Evaluate the Clinical Outcome by Assessment of Clinical Response.
Positive clinical response defined as resolution of diarrhea
Time frame: Day 10
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
Positive clinical response without recurrence through the follow-up period
Time frame: 28 days post-treatment
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