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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Chonnam National University Hospital; International Tuberculosis Research Center; Korean Center for Disease Control and Prevention; Korean Institute of Tuberculosis; National Medical Center, Seoul; Pusan National University Hospital; Pusan National University Yangsan Hospital; Seoul National University Bundang Hospital; Severance Hospital; SMG-SNU Boramae Medical Center
• Treatments: Ethambutol; Isoniazid; Pyrazinamide; Rifampin

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