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

• Status: Completed
• Trial end date: 2017-03-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Oxazolidinones; Vancomycin

Criteria

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