drugset / Trial / NCT01775397
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
Phase 4
Terminated
12 enrolled
Astellas Pharma Europe Ltd.
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
Timeline
- Start
- 2012-11-29
- Primary completion
- 2013-04-15
- Completion
- 2013-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fidaxomicin | Other / unclassified | — | — |
| Comparator | Vancomycin | Other / unclassified | — | Oral |