Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associa… (NCT01983683) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
631 participantsStarted 2013-12-12
Plain-language summary
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)
2
Clinical Cure Rate (CCR) in the Per-protocol Population
Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)