An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With Complicated Skin and Soft Tissue Infections (cSSTI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
研究概览
简要总结
The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daptomycin
Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.
干预措施: Daptomycin (Drug)
Vancomycin or Semi-Synthetic Penicillins (SSPs)
Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.
干预措施: Vancomycin or Semi-Synthetic Penicillins (SSPs) (Drug)
结局指标
主要结局
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
时间窗: Baseline and 7 to 14 days after end of therapy
Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
次要结局
- Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit(Baseline and 7 to 14 days after end of therapy)
- Duration of Treatment (Intravenous)(Up to 28 days)
- Duration of Treatment (Intravenous and Oral)(Up to 28 days)
- Number of Patients With Adverse Events, Serious Adverse Events and Death(Continuously from baseline up to 28 days after end of antibiotic treatment.)