NCT01818141

Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Detailed description

The purpose of this study is to: * Compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection * Compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of C. difficile infection having been treated with either fidaxomicin or vancomycin.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Vancomycin	Vancomycin 125mg by mouth every 6 hours for 10 days
DRUG	Fidaxomicin	Fidaxomicin 200mg by mouth every 12 hours for 10 days

Timeline

• Start date: 2012-10-17
• Primary completion: 2014-12-15
• Completion: 2014-12-15
• First posted: 2013-03-26
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

1 site across 1 country: United States