RANDOMISED CLINICAL TRIAL TO STUDY THE EFFICACY AND TOLERABILITY OF 3- AND 4-MONTH REGIMENS CONTAINING MOXIFLOXACIN IN THE TREATMENT OF PATIENTS WITH SPUTUM SMEAR AND CULTURE POSITIVE PULMONARY TUBERCULOSIS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,650
- 试验地点
- 2
- 主要终点
- Relapse rates in those with a favourable or doubtful bacteriological response at the end of treatment.
研究概览
简要总结
Shortening the duration of TB treatment is a research priority. The main aim of this study is to shorten the duration of TB treatment to 3 or 4 months compared to the standard treatment duration of 6 months, by strengthening the standard 4-drug TB regimen by the addition of moxifloxacin. Moxifloxacin has been shown to have potent bactericidal and sterilising activities against Mycobacterium tuberculosis. The safety of these regimens is also being monitored.
Enrollment to the study is in progress in Chennai and Madurai. As of the end oft December 2011, 605 patients have been enrolled in this trial out of a targeted sample size of 1650 patients. Interim analysis of the data has shown that patients treated with the moxifloxacin-containing regimens become sputum culture negative earlier and to a greater extent than those treated with the control regimen. Results at the end of treatment were similar for all the regimens, but TB recurrence was significantly higher in those treated with the 3-month moxifloxacin regimen compared to the other regimens. Based on the recommendation of the Data and Safety Monitoring Board (DSMB), recruitment to this arm has been temporarily suspended. Recruitment to the other four regimens of the trial is continuing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years to 60 years b.
- •Residing in or around Chennai or Madurai c.
- •No previous anti-TB treatment d.
- •At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy at enrollment e.
- •Willing to attend the treatment centre for supervised treatment f.
- •Willing for home visits by the staff of the center.
- •Willing to give written informed consent.
排除标准
- •Body weight less than 30 kgb.
- •Hepatic or renal disease as evidenced by clinical or biochemical abnormalitiesc.
- •Diabetes mellitusd.
- •History of seizure or loss of consciousnesse.
- •Psychiatric illnessf.
- •Abnormal electrocardiogram or anti-arrhythmic medication g.
- •Those in a moribund stateh.
- •Sero-positive for HIV antibodiesi.
- •Pregnancy or lactationj.
结局指标
主要结局
Relapse rates in those with a favourable or doubtful bacteriological response at the end of treatment.
时间窗: 24 months after completion of treatment
次要结局
- a) Sputum culture conversion at 2 months of treatment,b) Bacteriological response at end of treatment:c) Adverse reactions to anti-TB drugs(a) Sputum culture conversion at 2 months of treatment will be assessed at 5 months from start of treatment.d) Bacteriological response at end of treatment will be assessed at 6 to 9 months depending on the regimen.c) Adverse reactions to anti-TB drugs will be monitored throughout the treatment phase, 3 to 6 months depending on the regimen)