A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.
详细描述
This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 65 years of age.
- •Presence of CABP warranting hospitalization.
- •Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
- •Radiographically confirmed pneumonia.
排除标准
- •History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
- •Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
- •More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
- •Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR).
- •Evidence of significant hematologic, hepatic, or immunologic impairment.
研究组 & 干预措施
Ceftaroline fosamil
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
干预措施: Ceftaroline fosamil (Drug)
结局指标
主要结局
Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
时间窗: Between 3 and 33-37 days
Safety evaluations will be conducted and assessments will include: * Adverse events including deaths will be evaluated. * Laboratory: complete blood count with differential, and chemistry panel.
次要结局
- Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)(30 days following discharge from the hospital, anticipated between 33 to 37 days.)