NCT00600600已完成2 期
Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
研究概览
简要总结
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
详细描述
To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive cultures for rapidly growing mycobacteria
- •Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
- •Adults and children 10 years of age and older
- •Pretreatment isolate of M. avium complex available for MIC determination
- •Available for followup appointments
排除标准
- •History of tetracycline allergy
- •If a menstruating female, not pregnant and on adequate birth control
研究组 & 干预措施
Tigecycline
Experimental
tigecycline titrated dose according to patient age and clinical status
干预措施: Tigecycline (Drug)
结局指标
主要结局
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
时间窗: 6 mos
culture neg X3 ( sputum conversion)
次要结局
- clinical and Microbiological outcomes(6 mos)
研究者
Richard J. Wallace, Jr., M.D.
Chairman Department of Microbiology
The University of Texas Health Science Center at Tyler
研究点 (1)
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