Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
NCT ID: NCT04485156
Last Updated: 2020-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
926 participants
INTERVENTIONAL
2020-09-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Isoniazid
300mg
Pyrazinamide
20-30mg/kg
Ethambutol
15-20mg/kg
Rifampicin
10mg/kg
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
High-dose rifampicin
30mg/kg
Isoniazid
300mg
Pyrazinamide
20-30mg/kg
Interventions
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High-dose rifampicin
30mg/kg
Isoniazid
300mg
Pyrazinamide
20-30mg/kg
Ethambutol
15-20mg/kg
Rifampicin
10mg/kg
Eligibility Criteria
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Inclusion Criteria
* Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.
Exclusion Criteria
* 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
19 Years
85 Years
ALL
No
Sponsors
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Chonnam National University Hospital
OTHER
National Medical Center, Seoul
OTHER
Pusan National University Hospital
OTHER
Pusan National University Yangsan Hospital
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
Seoul National University Hospital
OTHER
Responsible Party
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Locations
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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, , South Korea
Countries
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References
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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.
Other Identifiers
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Hi-DoRi-3
Identifier Type: -
Identifier Source: org_study_id
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