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临床试验/NCT00081744
NCT00081744已完成3 期

A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 850 人开始时间: 2002年11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
850

研究概览

简要总结

Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

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
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms
  • Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline
  • Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

排除标准

  • Subjects who are moribund with an expected survival of less than 2 weeks.
  • Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy
  • Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

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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