A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

• Status: Completed
• Trial end date: 2016-05-05
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Fidaxomicin; Vancomycin

Criteria

Inclusion Criteria:

• CDI is confirmed by clinical symptoms (either > 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.

• Subject agrees not to participate in another interventional study whilst participating in this study.

Exclusion Criteria:

• Subject is taking or requiring to be treated with prohibited medications

• Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours

• Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment

• Subject is unable to swallow oral study medication.

• Subject has a current diagnosis of toxic megacolon.

• Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.

• Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.

• Subject has previously participated in a CDI vaccine study

• Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.