NCT00079989已完成3 期
A Phase 3, Open-label, Noncomparative Study of Tigecycline for the Treatment of Subjects With Selected Serious Infections Due to Resistant Gram-negative Organisms Such as Enterobacter Species, Acinetobacter Baumannii, and Klebsiella Pneumoniae
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 115 人开始时间: 2003年12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
- 115
研究概览
简要总结
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.
研究设计
- 研究类型
- Interventional
- 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
- •Male or female subjects aged 18 years or older
- •Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
- •Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections
排除标准
- •Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
- •Anticipated length of antibiotic therapy < 7 days
- •Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)
研究者
相似试验
已完成
3 期
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese SubjectsCommunity-Acquired InfectionsNCT00575094Wyeth is now a wholly owned subsidiary of Pfizer9
已完成
3 期
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)Gram-Positive Bacterial InfectionsStaphylococcus InfectionsVancomycin ResistanceMethicillin ResistanceNCT00079976Wyeth is now a wholly owned subsidiary of Pfizer174
撤回
3 期
Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric SubjectsSkin DiseasesInfectionNCT00911573Wyeth is now a wholly owned subsidiary of Pfizer
已完成
不适用
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)DiarrheaClostridium DifficileNCT01401023Gary E. Stein, Pharm.D.10
已完成
1 期
Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT01332786University Health Network, Toronto27