Phase 3
N=629
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Clostridium Infections · Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00314951 ↗Enrolled (actual)
629
Serious AEs
24.6%
Results posted
Oct 2011
Primary outcome: Primary: Cure Rate at End of Therapy — 85.7; 88.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fidaxomicin (Drug); Vancomycin (Drug); Matching Placebo to Fidaxomicin (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate at End of Therapy |
85.7; 88.2 | — |
| SECONDARY Recurrence |
25.1; 15.7 | 0.008 sig |
Summary
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
Eligibility Criteria
Inclusion Criteria
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion Criteria
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
Data sourced from ClinicalTrials.gov (NCT00314951). 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.