A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs 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 430 人开始时间: 2003年11月1日最近更新: 2013年2月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 430

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.

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 —（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 ag.
•Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
•The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature >38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95°

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 prior to the onset of symptoms
•Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

责任方

Sponsor

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