EUCTR2010-023491-25-NL进行中（未招募）不适用
Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis - Pharmacokinetics and safety of moxifloxacin
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •*Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture
- •*Starting treatment with MFX in a dose of 400 mg as part of their TB treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Contra-indication for MFX; Baseline QTc-interval > 450 msec
- •* History of resuscitation
- •* History of ventricular tachycardia (including Torsades de Pointes)
- •* Family history of sudden cardiac death or Torsades de Pointes
- •* Additional risk factors for Torsades de Pointes (including known heart failure, Left ventricular hypertrophy)
- •* Use of concomitant treatment with QT/QTc prolonging drugs (including anti-dysrhythmics class IA and III, antipsychotics, tricyclic antidepressants or the antihistaminic drug terfenadine)
- •* Abnormal electrolytes (K, Mg, Na, Ca)
- •* Abnormal cardiac repolarisation on screening/baseline ECG
- •* History of adverse events to fluoroquinolones
- •* HIV co-infection
- •* 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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