NCT01677871Unknown不适用
Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
研究概览
简要总结
During the Study:
- Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required
- The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients.
- Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment.
- Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required.
- The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females subjects aged 18-75 years.
- •Subjects with chronic liver disease (cirrhosis)
- •Pulmonary or extra-pulmonary tuberculosis.
- •Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.
- •consent and willingness to follow-up
排除标准
- •Serum ALT>5times upper limit and serum bilirubin >3 mg/dl.
- •Renal failure (serum creatinine>2mg/dl).
- •Presence of hepatocellular carcinoma
- •Alcoholic cirrhotic who continue to drink alcohol.
- •Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.
- •Known hypersensitivity to levofloxacin, other quinolones
研究组 & 干预措施
2HRZE/4HR
Experimental
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
干预措施: 2HRLE/4HR (Drug)
2HRLE/4HR
Active Comparator
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
干预措施: 2HRZE/4HR (Drug)
9HLE
Experimental
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
干预措施: 9RLE (Drug)
9RLE
Active Comparator
Rifampicin + Levofloxacin+ Ethambutol for 9 months
干预措施: 9HLE (Drug)
结局指标
主要结局
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
时间窗: 6 and 9 months
次要结局
- Survival(6 and 9 months)
- Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,(6 and 9 months)
- Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.
研究者
研究点 (1)
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