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Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

NCT01987895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2025-02-04

Study results available
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Summary

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Cadazolid

Cadazolid 250 mg as oral suspension twice daily.

DRUG

Vancomycin

Vancomycin 125 mg as oral capsules 4 times daily.

DRUG

Cadazolid-matching placebo

Placebo matching cadazolid and administered orally twice daily

DRUG

Vancomycin-matching placebo

Placebo capsules matching vancomycin and administered orally 4 times per day

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Anne Claire Marrast, MD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-27
Primary Completion
2017-02-26
Completion
2017-03-24
FDA Drug
Yes

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Entities

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 NCT01987895 on ClinicalTrials.gov