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Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea | Clinical Trials | Clareo Health

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

A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD).

NCT01983683•Actelion

View on ClinicalTrials.gov

Summary

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

Detailed Description

Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent.
•Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
•Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.

Exclusion Criteria

•More than one previous episode of CDAD in the 3-month period prior to randomization.
•Evidence of life-threatening or fulminant CDAD.
•Likelihood of death within 72 hours from any cause.
•History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
•Antimicrobial treatment active against CDAD administered for \> 24 hours except for metronidazole treatment failures (MTF)
•Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
•Unable or unwilling to comply with all protocol requirements.
•Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Key Dates

Start Date

December 12, 2013

Primary Completion Date

March 9, 2017

Completion Date

May 2, 2017

Last Updated

February 4, 2025

Enrollment

631

ACTUAL participants

Conditions

Clostridium Difficile Infection

Interventions

Cadazolid

DRUG

Vancomycin

DRUG

Cadazolid-matching placebo

DRUG

Vancomycin-matching placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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