CTRI/2019/05/019222招募中1 期
A Comparative study comparing intensified treatment with Moxifloxacin/Pyrazinamide versus standard Anti-tubercular therapy for CNS Tuberculoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduction in size/disappearance of Tuberculoma
研究概览
简要总结
- This is a prospective randomised clinical study comprising of 25 patients in each arm using random table method:Group A- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 2 drugs (INH, Rifampicin) in the maintenance phase. Group B- 5-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol and Moxifloxacin in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin and Moxifloxacin in the maintenance phase. Group C- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin, Pyrazinamide) in the maintenance phase. The aims and objectives are to compare the effect of the 3 regimens in the resolution of Brain Tuberculomas, to check if resolution of Tuberculomas begins faster with 5 drug regime or intensification of the 1st line drugs, to check the time taken for complete resolution of Tuberculomas in the three groups, to assess the post resolution residual damage to the brain between the three groups and to correlate the clinical features, cytokines level and neuroimaging. The recruitment phase of this study is for 18 months followed by 18 months of follow up with visits every 3 months with clinical exams and serial MRI imaging at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically and radiologically suspected cases of CNS tuberculoma.
排除标准
- •<18yrs, pregnant, HIV positive,refusal to participate in the study.
结局指标
主要结局
Reduction in size/disappearance of Tuberculoma
时间窗: 3 months, 6 months, 12 months, 18 months
次要结局
- Improvement in clinical parameters,symptoms and signs like headache,focal deficits and reduction in disability scores.
研究者
研究点 (1)
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