A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)

Actelion Pharmaceuticals Ltd0 个研究点目标入组 630 人开始时间: 2013年12月16日最近更新: 2018年3月12日

研究概览

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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 unformed bowel movements (UBM) within 24 hours prior to randomization,
•Positive C. difficile GDH and toxin test on the same stool sample produced within 72 hours prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 411
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 219

•- 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 or known positive diagnostic test for enteropathogens.
•- 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.

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