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
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
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).
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.