CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Vancomycin +1 moredrug
Likely dose
Vancomycin 125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01818141
NCT01818141Phase 4Completed
CompareCT.gov

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

Hartford Hospital·interventional·Posted Mar 26, 2013·Updated Jun 28, 2017

In Brief

A Phase 4 clinical trial evaluating Vancomycin and Fidaxomicin for Clostridium Difficile Infection. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
CountriesUnited States
CollaboratorsOptimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2013
Enrollment StartOct 17, 2012
Primary CompletionDec 15, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.3 years ago

Interventions

Vancomycindrug

Vancomycin 125mg by mouth every 6 hours for 10 days

Fidaxomicindrug

Fidaxomicin 200mg by mouth every 12 hours for 10 days