NCT02254967

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 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	Fidaxomicin	oral tablets administered in an extended pulsed regimen
DRUG	Vancomycin	oral capsule

Timeline

• Start date: 2014-11-06
• Primary completion: 2016-03-27
• Completion: 2016-05-05
• First posted: 2014-10-02
• Last updated: 2024-10-31

Locations

109 sites across 22 countries: Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom