A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 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
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
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 intra-abdominal infection that requires surgery within 24 hours.
- •Fever plus other symptoms such as nausea, vomiting, abdominal pain.
排除标准
- •Medicines that suppress the immune system
研究组 & 干预措施
A
干预措施: tigecycline (Drug)
B
干预措施: ceftriaxone plus metronidazole (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
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. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.
次要结局
- Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit(up to 6 weeks)
- Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit(up to 6 weeks)
- Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure(up to 6 weeks)