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 (EXTEND)

Astellas

Status and phase: Completed; Phase 4

Conditions: Clostridium Difficile

Treatments: Drug: Vancomycin; Drug: Fidaxomicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254967

2013-004619-31 (EudraCT Number)

2819-MA-1002

Details and patient eligibility

About

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).

Enrollment: 364 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

Fidaxomicin Extended Pulsed Regimen (EPFX)

Experimental group

Description:

Participants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.

Treatment:

Drug: Fidaxomicin

Vancomycin

Experimental group

Description:

Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.

Treatment:

Drug: Vancomycin