NCT01775397

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

Detailed description

On Day 1, subjects with diarrhea defined as having three or more unformed bowel movements or \>200 mL of unformed stool (for subjects having rectal collection devices) within 24 hours, confirmed by a rapid CDI test (positive for both toxins A \& B and glutamate dehydrogenase) to have CDI will be randomized to receive fidaxomicin or vancomycin (1:1 randomization). Subjects will be treated with study medication from Day 1 to Day 10. Assessment for clinical cure (Test of Cure \[TOC\]) will take place 48 - 72 hours after End of Treatment (EOT). Subjects not meeting the definition of clinical cure at TOC will be defined as treatment failures. A stool sample for evaluation of microbial cure will be taken at TOC on Day 12. Subjects meeting the criteria for clinical cure at TOC will be monitored for recurrence until 28 days after TOC (Day 40). Treatment of subjects with recurrence of CDI will be at the discretion of the Investigator. Subjects not meeting the criteria for clinical cure at TOC will be followed for safety until Day 40. Further CDI treatment will be at the discretion of the Investigator. The strain of Clostridium difficile will be determined for all samples.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	Fidaxomicin	capsule
DRUG	Vancomycin	capsule
DRUG	Placebo	Capsule

Timeline

• Start date: 2012-11-29
• Primary completion: 2013-04-15
• Completion: 2013-04-15
• First posted: 2013-01-25
• Last updated: 2020-01-13

Locations

16 sites across 7 countries: Austria, Denmark, France, Germany, Greece, Poland, Spain