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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02254967
• Date of registration: 25/09/2014
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe Ltd.
• Public title: 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
• Scientific title: A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population
• Date of first enrolment: November 6, 2014
• Target sample size: 364
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254967
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Austria, Belgium, Croatia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Medical Director
• Affiliation: Astellas Pharma Europe Ltd.

Key inclusion & exclusion 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Clostridium Difficile

Intervention(s)

Drug: Vancomycin

Drug: Fidaxomicin

Primary Outcome(s)

Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment [Time Frame: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])]

Secondary Outcome(s)

Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90 [Time Frame: Day 40, 55, 90]

Disease-free Survival After Day 10 [Time Frame: From day 10 up to day 90]

Time to Resolution of Diarrhea (TTROD) [Time Frame: Up to day 10 (for vancomycin) or up to day 25 (for EPFX)]

Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates [Time Frame: Baseline through day 90]

Percentage of Participants with a Clinical Response of CDI at Day 12 [Time Frame: Day 12]

Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90 [Time Frame: Day 40, 55, 90]

Time to Recurrence of CDI after End of Active Treatment [Time Frame: From day 10 up to day 90]

Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment [Time Frame: Day 12, 27]

Secondary ID(s)

2013-004619-31

2819-MA-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.