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Not yet recruiting NCT04485156

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

Phase III Interventional Tuberculosis, Pulmonary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-dose rifampicin, Isoniazid, Pyrazinamide, Ethambutol.
Who it may be relevant to
Registry conditions: Tuberculosis, Pulmonary. Basic parameters: 19 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug High-dose rifampicin
    30mg/kg
  • Drug Isoniazid
    300mg
  • Drug Pyrazinamide
    20-30mg/kg
  • Drug Ethambutol
    15-20mg/kg
  • Drug Rifampicin
    10mg/kg

Primary outcome measures

  • Incidence of unfavorable treatment outcomes between two arms [Time frame: Within 18 months of randomization]
Secondary outcome measures (6)
  • Time to unfavorable treatment outcomes [Time frame: Within 18 months of randomization]
  • Time to culture conversion on liquid media [Time frame: Censored at 2 months of treatment]
  • Proportion of participants with treatment success [Time frame: At the end of treatment]
  • Proportion of participants with relapse of same strain [Time frame: At the end of study]
  • Time to relapse with same strain [Time frame: through study completion, 18months after randomization]
  • Occurrence of AEs grade 3 and above [Time frame: through study completion, 18months after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lu — Seoul

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. PMID 39343425
  • 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/s13063-022-0663 PMID 35978342

Identifiers

NCT: NCT04485156 · Hi-DoRi-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗