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Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

NCT00314951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2017-04-21

Study results available
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Summary

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Conditions

Interventions

DRUG

Fidaxomicin

200 mg oral capsules two times daily (q12h regimen)

DRUG

Vancomycin

125 mg capsules q6hr (4 times a day)

DRUG

Matching Placebo to Fidaxomicin

Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

Sponsors & Collaborators

  • Optimer 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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-02
Primary Completion
2008-07-23
Completion
2008-08-21

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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 NCT00314951 on ClinicalTrials.gov