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Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

NCT01597505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2019-07-23

Study results available
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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.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Surotomycin

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

DRUG

Vancomycin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-16
Primary Completion
2015-03-20
Completion
2015-03-20

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597505 on ClinicalTrials.gov