Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
试验速览
- 阶段
- 不适用
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
研究概览
简要总结
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
详细描述
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, alternative shortened courses such as 1-month daily rifapentine and isoniazid have been evaluated in HIV-infected individuals for its non-inferiority, safety and convenience compared with traditional monotherapy. And the treatment completion rate is higher. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.
Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Individuals with Silica exposure or diagnosed with silicosis;
- •Age between 18 to 65 years;
- •Willing to provide signed informed consent, or parental consent and participant assent.
排除标准
- •Clinical or culture confirmed active TB;
- •A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years;
- •A documented history of a completing an adequate course of treatment for active TB or latent TB infection;
- •Allergy to Isoniazid, Rifampin, or Rifapentine;
- •Human immunodeficiency virus (HIV) infection;
- •History of hepatitis B/C infection or liver cirrhosis;
- •Serum Aspartic transaminase (AST) or alanine transaminase (ALT) > 2x upper limit of normal or total bilirubin >2.5 mg/dL;
- •Receiving immunosuppressants or biological agents;
- •Life expectancy <3 years;
- •Mental disorder;
- •Participated in other clinical trials in recent three months;
- •Other conditions that investigates consider not suitable for participate.
研究组 & 干预措施
Isoniazid/ Rifapentine 3 times a week
Intervention：Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses
干预措施: Isoniazid；Rifapentine (Drug)
结局指标
主要结局
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
时间窗: 3 years
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants
次要结局
- Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH(up to 30 days after the last dose of study drug)
- Percentage of participants who complete the treatment regimen(Enrollment up to Month 1 (1RPT/INH))
- Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH(up to 30 days after the last dose of study drug)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital