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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04485156
Acronym
Hi-DoRi-3
Enrollment
926
Registered
2020-07-24
Start date
2020-09-30
Completion date
2026-12-31
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pulmonary

Keywords

Tuberculosis, Rifampicin, Treatment, Shortening

Brief 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.

Interventions

DRUGHigh-dose rifampicin

30mg/kg

DRUGIsoniazid

300mg

DRUGPyrazinamide

20-30mg/kg

DRUGEthambutol

15-20mg/kg

DRUGRifampicin

10mg/kg

Sponsors

Chonnam National University Hospital
CollaboratorOTHER
National Medical Center, Seoul
CollaboratorOTHER
Pusan National University Hospital
CollaboratorOTHER
Pusan National University Yangsan Hospital
CollaboratorOTHER
Seoul National University Bundang Hospital
CollaboratorOTHER
SMG-SNU Boramae Medical Center
CollaboratorOTHER
Severance Hospital
CollaboratorOTHER
Korean Institute of Tuberculosis
CollaboratorOTHER
International Tuberculosis Research Center
CollaboratorOTHER
Korean Center for Disease Control and Prevention
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of unfavorable treatment outcomes between two armsWithin 18 months of randomization

Secondary

MeasureTime frame
Time to unfavorable treatment outcomesWithin 18 months of randomization
Time to culture conversion on liquid mediaCensored at 2 months of treatment
Occurrence of AEs grade 3 and abovethrough study completion, 18months after randomization
Proportion of participants with relapse of same strainAt the end of study
Time to relapse with same strainthrough study completion, 18months after randomization
Proportion of participants with treatment successAt the end of treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026