A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 784
- 主要终点
- Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
研究概览
简要总结
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.
详细描述
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of an infection consistent with complicated skin and skin structure infections.
排除标准
- •Known or suspected hypersensitivity to any study medication
- •Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
- •Previous enrollment in this study
- •Treatment with any investigational drug within 30 days before enrollment.
研究组 & 干预措施
Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
干预措施: Ceftobiprole medocaril (Drug)
Vancomycin
Vancomycin 1g q12h as 1h infusion, 7-14d
干预措施: Vancomycin (Drug)
结局指标
主要结局
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
时间窗: 7 weeks
次要结局
- Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.(7 weeks)