Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
Phase 3
Not yet recruiting
- Conditions
- Tuberculosis, Pulmonary
- Interventions
- Registration Number
- NCT04485156
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 926
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 (High-dose rifampicin group) Pyrazinamide 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 Arm 2 (High-dose rifampicin group) High-dose rifampicin 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 Arm 1 (Conventional treatment group) Isoniazid 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 Arm 1 (Conventional treatment group) Ethambutol 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 Arm 1 (Conventional treatment group) Pyrazinamide 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 Arm 1 (Conventional treatment group) Rifampicin 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 Arm 2 (High-dose rifampicin group) Isoniazid 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
- Primary Outcome Measures
Name Time Method Incidence of unfavorable treatment outcomes between two arms Within 18 months of randomization
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
🇰🇷Seoul, Korea, Republic of