NCT00081575已完成3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 434 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 434
- 主要终点
- Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
研究概览
简要总结
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
- •Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
- •The presence of fever (within 24 hours before randomization)
排除标准
- •Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy <30 days).
- •Hospitalization within 14 days before the onset of symptoms.
- •Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms.
结局指标
主要结局
Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Determine whether tigecycline is noninferior to levofloxacin.
次要结局
未报告次要终点
研究者
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