Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 926
- 试验地点
- 1
- 主要终点
- Incidence of unfavorable treatment outcomes between two arms
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented positivity by sputum Xpert MTB/RIF assay
- •Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.
排除标准
- •Negative on Xpert MTB/RIF assay
- •Resistance to rifampicin as detected by an Xpert MTB/RIF assay
- •Known resistance to isoniazid, rifampicin, or pyrazinamide
- •HIV positive
- •Cancer patient on anti-cancer chemotherapy
- •Uncontrolled DM
- •Chronic hepatitis, liver cirrhosis
- •Any contraindications of drugs to be used
研究组 & 干预措施
Arm 1 (Conventional treatment group)
Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment
- 6 months in total
干预措施: Isoniazid (Drug)
Arm 1 (Conventional treatment group)
Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment
- 6 months in total
干预措施: Pyrazinamide (Drug)
Arm 1 (Conventional treatment group)
Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment
- 6 months in total
干预措施: Ethambutol (Drug)
Arm 1 (Conventional treatment group)
Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment
- 6 months in total
干预措施: Rifampicin (Drug)
Arm 2 (High-dose rifampicin group)
High-dose rifampicin, isoniazid, and pyrazinamide
- Rifampicin: 30mg/kg
- Isoniazid: 300mg/day
- Pyrazinamide: 1000mg/day (<50kg), 1500mg/day (50-70kg), 2000mg /day (>70kg), till culture conversion Duration of the treatment
- Till 12 weeks after culture conversion on liquid media
干预措施: High-dose rifampicin (Drug)
Arm 2 (High-dose rifampicin group)
High-dose rifampicin, isoniazid, and pyrazinamide
- Rifampicin: 30mg/kg
- Isoniazid: 300mg/day
- Pyrazinamide: 1000mg/day (<50kg), 1500mg/day (50-70kg), 2000mg /day (>70kg), till culture conversion Duration of the treatment
- Till 12 weeks after culture conversion on liquid media
干预措施: Isoniazid (Drug)
Arm 2 (High-dose rifampicin group)
High-dose rifampicin, isoniazid, and pyrazinamide
- Rifampicin: 30mg/kg
- Isoniazid: 300mg/day
- Pyrazinamide: 1000mg/day (<50kg), 1500mg/day (50-70kg), 2000mg /day (>70kg), till culture conversion Duration of the treatment
- Till 12 weeks after culture conversion on liquid media
干预措施: Pyrazinamide (Drug)
结局指标
主要结局
Incidence of unfavorable treatment outcomes between two arms
时间窗: Within 18 months of randomization
次要结局
- Time to unfavorable treatment outcomes(Within 18 months of randomization)
- Time to culture conversion on liquid media(Censored at 2 months of treatment)
- Proportion of participants with treatment success(At the end of treatment)
- Proportion of participants with relapse of same strain(At the end of study)
- Time to relapse with same strain(through study completion, 18months after randomization)
- Occurrence of AEs grade 3 and above(through study completion, 18months after randomization)