Not Yet RecruitingPhase 3

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

South Korea926 participantsStarted 2020-09

Plain-language 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.

Who can participate

Age range19 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of unfavorable treatment outcomes between two arms

Timeframe: Within 18 months of randomization

Trial details

NCT IDNCT04485156

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

View on ClinicalTrials.gov More Tuberculosis, Pulmonary trials