Phase 3
N=535
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Clostridium Infections · Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00468728 ↗Enrolled (actual)
535
Serious AEs
24.4%
Results posted
Jul 2011
Primary outcome: Primary: Cure Rate at End of Therapy — 86.7; 87.7 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PAR-101/OPT-80 (Drug); Vancomycin (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
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate at End of Therapy |
86.7; 87.7 | — |
| SECONDARY Recurrence |
27.0; 12.6 | <0.001 sig |
| SECONDARY Global Cure |
63.3; 76.7 | 0.001 sig |
Summary
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (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 (NCT00468728). 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.