A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 638
- 主要终点
- Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug
研究概览
简要总结
The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.
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 community-acquired pneumonia. 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 community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.
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
- •Patients suffering from community-acquired pneumonia severe enough to require hospitalization
- •Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study
排除标准
- •Patients with known or suspected hypersensitivity to any related antibiotic medications
- •Treatment with any experimental drug within 30 days before enrollment
- •Prior enrollment in this study or any study with ceftobiprole medocaril
研究组 & 干预措施
Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
干预措施: Ceftobiprole medocaril (Drug)
Ceftriaxone with or without Linezolid
Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d
干预措施: Ceftriaxone with or without Linezolid (Drug)
结局指标
主要结局
Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug
时间窗: 7 weeks
次要结局
- Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)(7 weeks)