drugset / Trial / NCT04485156
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
Phase 3
Not yet recruiting
926 enrolled
Seoul National University Hospital
Chonnam National University Hospital · collabInternational Tuberculosis Research Center · collabKorean Center for Disease Control and Prevention · collabKorean Institute of Tuberculosis · collabNational Medical Center, Seoul · collabPusan National University Hospital · collabPusan National University Yangsan Hospital · collabSMG-SNU Boramae Medical Center · collabSeoul National University Bundang Hospital · collabSeverance Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-09
- Primary completion
- 2025-08
- Completion
- 2026-12
Outcome
Missed primary endpoint
paper The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. PMID 39343425 ↗
paper The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile. PMID 39343425 ↗
Publications
- Kwak N, Kim JY, Kim HJ, Kwon BS, Lee JH, Mok J, Kwon YS, Kang YA, Park Y, Lee JY, Jeon D, Lee JK, Yang JS, Whang J, Kim KJ, Kim YR, Cheon M, Park J, Hahn S, Yim JJ. High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis. Tuberc Respir Dis (Seoul). 2025 Jan;88(1):170-180. doi: 10.4046/trd.2024.0099. Epub 2024 Sep 27.
- Kwak N, Jeon D, Park Y, Kang YA, Kim KJ, Kim YR, Kwon BS, Kwon YS, Kim HJ, Lee JH, Lee JY, Lee JK, Mok J, Cheon M, Park J, Hahn S, Yim JJ. Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial. Trials. 2022 Aug 17;23(1):666. doi: 10.1186/s13063-022-06631-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | 15 mg/kg | — |
| Comparator | Ethambutol | Small molecule | 20 mg/kg | — |
| Subject | Rifampicin | Small molecule | 10 mg/kg | — |
| Subject | Rifampicin | Small molecule | 30 mg/kg | — |
| Background | Isoniazid | Small molecule | 300 mg | — |
| Background | Pyrazinamide | Small molecule | 20 mg/kg | — |
| Background | Pyrazinamide | Small molecule | 30 mg/kg | — |
| Background | Pyrazinamide | Small molecule | 1000 mg | — |
| Background | Pyrazinamide | Small molecule | 1500 mg | — |
| Background | Pyrazinamide | Small molecule | 2000 mg | — |