NL-OMON36271已完成4 期
Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis - Pharmacokinetics and safety of moxifloxacin
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture
- •2) Starting treatment with MFX in a dose of 400 mg as part of their TB treatment
排除标准
- •1) Contra-indication for moxifloxacin; baseline QTc-interval > 450 msec
- •2) History of resuscitation
- •3) History of ventricular tachycardia (including Torsades de Pointes)
- •4) Family history of sudden cardiac death or Torsades de Pointes
- •5) Additional risk factors for Torsades de Pointes (including known heart failure, Left ventricular hypertrophy)
- •6) Use of concomitant treatment with QT/QTc prolonging drugs (including anti-dysrhythmics class IA and III, antipsychotics, tricyclic antidepressants or the antihistaminic drug terfenadine)
- •7) Abnormal electrolytes (K, Mg, Na, Ca)
- •8) Abnormal cardiac repolarisation on screening/baseline ECG
- •9) History of adverse events to fluoroquinolones
- •10) HIV co-infection
- •11) RIF treatment during last 3 weeks before start of the study. After a washout period of 3 weeks the patient can be included.
研究者
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