A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY AND SAFETYOF CADAZOLID VERSUS VANCOMYCIN IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATEDDIARRHEA (CDAD)

Not Applicable

• Conditions: -A047 Enterocolitis due to Clostridium difficile; Enterocolitis due to Clostridium difficile; A047

• Registration Number: PER-087-13
• Lead Sponsor: Actelion Pharmaceuticals Ltd,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 1

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 (by enzyme immunoassay approved by the sponsor) 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. Inability to take oral medication, or subjects with feeding tubes. Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF). Planned treatment with forbidden concomitant medications. Fecal microbiota transplant (FMT), immunoglobulin therapy, and investigational drug to prevent or treat CDAD within 1 month prior to randomization Monoclonal antibodies against C. difficile within 6 months prior to randomization.
Previous vaccination against C. difficile. Previous participation in a clinical trial with cadazolid. Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones. Females who are breastfeeding. Investigational site staff members or relatives, and Actelion employees. Unable or unwilling to comply with all protocol requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified