Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Europe Ltd.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Clostridium Difficile
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2016
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT02254967
Start Date
November 6 2014
End Date
May 5 2016
Last Update
October 31 2024
Active Locations (109)
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1
Site AT43002
Graz, Austria, 8020
2
Site AT43003
Linz, Austria, 4010
3
Site AT43001
Salzburg, Austria, 5020
4
Site BE32007
Aalst, Belgium, 9300