A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 57
- 主要终点
- Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of complicated skin or skin structure infection
- •Male or female, 18 years or older
- •Need for intravenous treatment for 4 to 14 days
排除标准
- •Skin infection that can be treated by surgery & wound care alone
- •Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
- •Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
研究组 & 干预措施
1
Arm 1: Tigecycline
干预措施: Tigecycline (Drug)
2
Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
干预措施: ampicillin-sulbactam (Drug)
结局指标
主要结局
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
时间窗: up to 6 weeks
Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.
次要结局
- Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit(up to 6 weeks)
- Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit(up to 6 weeks)
- Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate(up to 6 weeks)
- Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients(up to 6 weeks)