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

Actelion Pharmaceuticals Ltd,0 个研究点目标入组 1 人开始时间: 2014年3月4日最近更新: 2023年9月4日

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•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.

•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.

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