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| Name | Class |
|---|---|
| Chonnam National University Hospital | OTHER |
| National Medical Center, Seoul | OTHER |
| Pusan National University Hospital | OTHER |
| Pusan National University Yangsan Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Conventional treatment group) | Active Comparator | 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) | Experimental | High-dose rifampicin, isoniazid, and pyrazinamide
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose rifampicin | Drug | 30mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unfavorable treatment outcomes between two arms | Within 18 months of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39343425 | Derived | 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. | |
| 35978342 |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D007538 | Isoniazid |
| D011718 | Pyrazinamide |
| D004977 | Ethambutol |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Seoul National University Bundang Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Severance Hospital | OTHER |
| Korean Institute of Tuberculosis | OTHER |
| International Tuberculosis Research Center | OTHER |
| Korean Center for Disease Control and Prevention | OTHER_GOV |
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| Isoniazid |
| Drug |
300mg |
|
| Pyrazinamide | Drug | 20-30mg/kg |
|
| Ethambutol | Drug | 15-20mg/kg |
|
| Rifampicin | Drug | 10mg/kg |
|
| 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 |
| 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011719 | Pyrazines |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |