A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 622
- 试验地点
- 8
- 主要终点
- Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
研究概览
简要总结
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
详细描述
Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
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
- •Subjects with community-acquired pneumonia requiring:
- •initial hospitalization or treatment in an emergency room or urgent care setting
- •infection requiring initial treatment with IV antimicrobial
排除标准
- •Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
- •Respiratory tract infections not due to community-acquired bacterial pathogens
- •Infections resistant to ceftriaxone
- •Any condition requiring concomitant systemic corticosteroids
- •History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
研究组 & 干预措施
Ceftaroline fosamil for injection
Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
干预措施: Ceftaroline fosamil for Injection (Drug)
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
干预措施: Ceftriaxone (Drug)
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
时间窗: 8-15 days after last dose of study drug
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: * Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy * Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia * Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population
时间窗: 8-15 days after last dose of study drug
次要结局
- Clinical and Microbiological Response by Pathogen at TOC(8-15 days after last dose of study drug)
- Clinical Response at End of Therapy (EOT)(Last day of study drug administration)
- Microbiological Success Rate at TOC(8-15 days after last dose of study drug)
- Overall Clinical and Radiographic Success Rate at TOC(8-15 days after last dose of study drug)
- Clinical Relapse at Late Follow Up (LFU) Visit(21-35 days after last dose of study drug)
- Microbiological Reinfection/Recurrence at LFU(21 to 35 days after last dose of study drug)
- Evaluate Safety(first dose, throughout the treatment period, and up to the TOC visit)