CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 606 enrolled
Drug / intervention
Surotomycin +2 moredrug
Likely dose
Surotomycin 250 mgfrom 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/NCT01597505
NCT01597505Phase 3Completed
CompareCT.gov

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted May 14, 2012·Updated Jul 23, 2019

In Brief

A Phase 3 clinical trial evaluating Surotomycin, Vancomycin, and 1 other intervention for Clostridium Difficile Infection. Completed, enrolled 606 participants.

Detailed Summary

606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2012
Enrollment StartMay 16, 2012
Primary CompletionMar 20, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.1 years ago

Interventions

Surotomycindrug

250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days

Vancomycindrug

125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days

Placebodrug

Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days