A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
研究概览
简要总结
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
详细描述
Ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00248) and another similar study (BAP00307, see NCT00210964) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248 Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion 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
- Triple (Participant, Care Provider, Investigator)
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 nosocomial pneumonia or ventilator-associated pneumonia
- •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, and have a negative serum or urine pregnancy test at the screening
排除标准
- •Known or suspected hypersensitivity to any related antibiotic medications
- •Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
- •Treatment with any investigational drug within 30 days before enrollment
- •Prior enrollment to this study
研究组 & 干预措施
001
ceftobiprole plus placebo ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
干预措施: ceftobiprole plus placebo (Drug)
002
linezolid plus ceftazidime linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
干预措施: linezolid plus ceftazidime (Drug)
结局指标
主要结局
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
时间窗: 7 to 14 days after the end of therapy (EOT)
次要结局
- Microbiological eradication rate(At the TOC visit defined as 7-14 days after the EOT)
- Clinical cure rate(At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT)
- Microbiological eradication rates(At the LFU visit defined as 28 to 35 days after the EOT)
- Pneumonia-specific mortality rates(Within 30 days after the randomization)