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Tuberculosis, PulmonaryPhase 3Hi-DoRi-3NCT04485156

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

A Phase 3 study testing High-dose rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
High-dose rifampicin, Isoniazid and Pyrazinamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
926 participants
Where
1 siteSouth Korea
Study dates
Sep 2020to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • 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

Other trials in South Korea

About this study

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

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.

Being tested
High-dose rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Rifampicin
Keywords
Tuberculosis, Rifampicin, Treatment, Shortening
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-dose rifampicinDrug

    30mg/kg

  • IsoniazidDrug

    300mg

  • PyrazinamideDrug

    20-30mg/kg

  • EthambutolDrug

    15-20mg/kg

  • RifampicinDrug

    10mg/kg

Study groups in NCT04485156
Study groupRoleWhat they receive
Arm 1 (Conventional treatment group)Active comparatorWill 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
Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Rifampicin
Arm 2 (High-dose rifampicin group)ExperimentalHigh-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
Receives: Drug: High-dose rifampicin; Drug: Isoniazid; Drug: Pyrazinamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of unfavorable treatment outcomes between two arms

    Measured: Within 18 months of randomization

Secondary outcomes (6)

  1. Time to unfavorable treatment outcomes

    Measured: Within 18 months of randomization

  2. Time to culture conversion on liquid media

    Measured: Censored at 2 months of treatment

  3. Proportion of participants with treatment success

    Measured: At the end of treatment

  4. Proportion of participants with relapse of same strain

    Measured: At the end of study

  5. Time to relapse with same strain

    Measured: through study completion, 18months after randomization

  6. Occurrence of AEs grade 3 and above

    Measured: through study completion, 18months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
926 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485156
Sponsor's protocol ID
Hi-DoRi-3
Acronym
Hi-DoRi-3
Status last verified
Jul 2020
First submitted
6 Jul 2020
Last updated
24 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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/s13063-022-06631-z.

    PubMed 35978342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High-dose rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of unfavorable treatment outcomes between two arms (time frame: Within 18 months of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485156, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.

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