A Randomised Open-Label Controlled Trial of a 4-Month Gatifloxacin-Containing Regimen Versus Standard Regimen for the Treatment of Adult Patients With Pulmonary Tuberculosis
试验速览
- 阶段
- 3 期
- 入组人数
- 2,070
- 试验地点
- 5
- 主要终点
- Efficacy: Percentage of relapses by 24 months following treatment cure
研究概览
简要总结
Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,
详细描述
In order to evaluate the efficacy and safety of the 4-month test gatifloxacin-containing regimen, comparison will be made with a standard 6-month regimen, recommended by WHO. Patients will be treated with one of the two regimens that will be randomly allocated. A total of 2070 patients will ne recruited in the trial and followed-up for a duration of 2 years. The trial is multicentre, and conducted in 5 countries in Africa.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Aged 18 to 65 years
- •Currently suffering from recently diagnosed microscopically proven pulmonary tuberculosis and providing informed consent for inclusion in the study.
排除标准
- •Patients with history of tuberculosis treatment within the last 3 years
- •History of diabetes mellitus or non insulin dependent diabetes mellitus requiring treatment
- •Concomitant infection requiring additional anti-infective treatment (especially anti-retroviral therapy)
- •HIV infected patients with WHO stage 3 infection - except those presenting with only the "loss of weight>10% body weight" criterion - and all HIV infected patients at WHO stage 4.
结局指标
主要结局
Efficacy: Percentage of relapses by 24 months following treatment cure
Safety: Percentage of adverse events
次要结局
- Efficacy: Time to relapse
- Efficacy: Percentage of smear and culture conversion at 8 weeks
- Efficacy: Percentage of patient cured at the end of treatment
- Efficacy: Time to a composite "unsatisfactory" endpoint
- Safety outcome: Distribution of type and grading of adverse events