Phase 2
Completed N=38
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Clostridium Difficile-associated Diarrhea
Source: ClinicalTrials.gov NCT01591863 ↗
Enrolled (actual)
38
Serious AEs
23.7%
Results posted
Mar 2015
Primary outcomePrimary: Number of Participants With Adverse Events. — 28 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
28 | — |
| PRIMARY Investigate Concentrations of Fidaxomicin in Plasma Samples. |
13.363 | — |
| PRIMARY Investigate Concentrations of Fidaxomicin in Fecal Samples. |
3227.93 | — |
| PRIMARY Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. |
60.016 | — |
| PRIMARY Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. |
865.49 | — |
| SECONDARY Evaluate the Clinical Outcome by Assessment of Clinical Response. |
92.1 | — |
| SECONDARY Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. |
65.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01591863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.