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Fidaxomicin in pediatric CDAD
NCT01591863Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Mar 2014
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- fidaxomicin
- Conditions
- Clostridioides difficile infection (CDI)
01
Overview
Phase 2, open-label, single-arm trial of fidaxomicin in Clostridioides difficile infection (CDI), sponsored by Merck & Co. Primary endpoints: Number of Participants With Adverse Events, Investigate Concentrations of Fidaxomicin in Plasma Samples and 3 more. Started Jun 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Fidaxomicin
Fidaxomicin oral suspension or tablets for 10 days
03
Endpoints
Primary
Number of Participants With Adverse Events
Investigate Concentrations of Fidaxomicin in Plasma Samples
Investigate Concentrations of Fidaxomicin in Fecal Samples
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples
Secondary
Evaluate the Clinical Outcome by Assessment of Clinical Response
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response
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