NCT01055145终止3 期
Comparison of the Effect Between Levofloxacin and Moxifloxacin on the Culture Conversion After 3 Months Treatment Among MDR-TB Patients; Prospective Multicenter Randomized Open Label Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 182
- 试验地点
- 29
- 主要终点
- Negative conversion of M. tuberculosis
研究概览
简要总结
Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin
排除标准
- •Achieved negative conversion of M. TB culture before the enrollment
- •Positive anti-HIV antibody
- •Pregnant women or sexually active women without using proper birth control method
- •Serum creatine grater than 2mg/dL, or urine protein greater than 2+
- •Serum total bilirubin greater than 2 mg/dL or AST and ALT greater than 1.5 times of normal upper limit
- •History or current arrhythmia
- •Hypersensitivity to levofloxacin, moxifloxacin,or rifabutin
- •Should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly
研究组 & 干预措施
levofloxacin
Active Comparator
Levofloxacin 750mg po per day for 3 months
干预措施: levofloxacin, moxifloxacin (Drug)
moxifloxacin
Active Comparator
Moxifloxacin 400mg po per day for 3 months
干预措施: levofloxacin, moxifloxacin (Drug)
结局指标
主要结局
Negative conversion of M. tuberculosis
时间窗: 3 months after initiation of treatment
次要结局
未报告次要终点
研究者
研究点 (29)
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