A Randomized Multicenter Clinical Trial of a New Treatment for Primary Smear- Positive Pulmonary Tuberculosis With Interleukin-2
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,100
- 试验地点
- 16
- 主要终点
- The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis.
详细描述
- Design:The study is a multi-center, randomized, controlled, open clinical trial.
- Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
- Investigational regimens:
Experimental group regimen:2HRZE/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） The control group regimen: 2HRZE/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). 4. Primary and Secondary outcome measures:
primary efficacy outcome measures:(a)Negative conversion rate of sputum bacteria. (b)Sputum smear conversion proportion at the treatment completion .
secondary efficacy outcome measure:Recurrence rate after treatment.
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
- •Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
- •Is aged 18-65 years.
- •Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive.
- •Newly diagnosed cases receiving anti-TB treatment for less than one month.
- •No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
- •the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period.
排除标准
- •Has a known allergy to any drug of treatment regimens.
- •There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L.
- •Complication with Diabetic.
- •The screening diagnosis was isoniazid resistance or rifampin resistance
- •There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
- •Is known to be pregnant or breast-feeding.
- •Karnofsky score is less than 50%.
- •Is taking any clinical trial in the past 3 months.
- •Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
- •HIV is positive or AIDS patients.
- •Has Non tuberculous mycobacterial lung disease.
- •Merge with extra pulmonary tuberculosis.
研究组 & 干预措施
experimental group
Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month）
Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
干预措施: Interleukin-2 (Drug)
Control regimen group
The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR
Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
时间窗: two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).
A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.
次要结局
未报告次要终点
研究者
Chu naihu
Director,TB Department
Beijing Chest Hospital