CompletedPhase 2

Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

United States84 participantsStarted 2011-01-25

Plain-language summary

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Male or female * At least 18 years of age * With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence. Key Exclusion Criteria: * Concurrent life threatening condition. * Immuno-compromised subjects, concomittant immuno-suppresive treatment. * Concomitant antimicrobial treatment for CDAD. * Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol

What they're measuring

Clinical cure rate at test-of-cure

Timeframe: Day 13 or 24-72 hours after end of treatment

Trial details

NCT IDNCT01222702

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10-16

View on ClinicalTrials.gov More Clostridium Difficile Infection trials