New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 864
- 试验地点
- 1
- 主要终点
- success rate
研究概览
简要总结
Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients.
To obtain optimized short-course regimen, decrease treatment cost and improve success rate.
详细描述
China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.
Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.
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
- •Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
- •Must be able to swallow tablets
- •Must be able to sign written informed consent form
排除标准
- •Extra-pulmonary tuberculosis
- •Allergy to any of the medications in the regimen or pregnancy
- •Liver disease
- •Renal disease
- •Metabolic disease
- •Immune system disease
- •Hematological disease
- •Nervous system and mental disease
- •Endocrine disease
- •Malignant disease
- •Receiving immunosuppressive therapy
- •Alcohol addiction
研究组 & 干预措施
arm A: super-short retreatment regimen
A regimen of 5 drugs is to be administered. Isoniazid Aminosalicylate Tablets,0.3g tid po for 5 mon moxifloxacin tab, 0.4g qd po for 5 mon rifabutin capsule,0.3g qd po for 5 mon ethambutol tab, 0.75g qd po for 5 mon pyrazinamide tab, 0.5g tid po for 5 mon
干预措施: Isoniazid Aminosalicylate Tablets (Drug)
arm B:standardized retreatment regimen
8-9 months of standardized regimen is to be administered. regimen 1.2SHREZ/6HRE streptomycin injectable,0.75g qd intramuscular for 2 mon isoniazid tab,0.3g qd po for 8 mon rifampicin capsule,0.45-0.6g po for 8 mon ethambutol tab, 0.75g qd po for 8 mon pyrazinamide tab, 0.5g tid po for 2 mon or regimen 2.3HREZ/6HRE isoniazid tab,0.3g qd po for 9 mon rifampicin capsule,0.45-0.6g po for 9 mon ethambutol tab, 0.75g qd po for 9 mon pyrazinamide tab, 0.5g tid po for 3 mon
干预措施: Streptomycin injectable (Drug)
结局指标
主要结局
success rate
时间窗: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
次要结局
- adverse reaction rate(for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.)
研究者
Qing Zhang
Chief physician
Shanghai Pulmonary Hospital, Shanghai, China