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

Seoul National University

Status and phase: Not yet enrolling; Phase 3

Conditions: Tuberculosis, Pulmonary

Treatments: Drug: Rifampicin; Drug: Ethambutol; Drug: High-dose rifampicin; Drug: Isoniazid; Drug: Pyrazinamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04485156

Hi-DoRi-3

Details and patient eligibility

About

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.

Enrollment: 926 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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926 participants in 2 patient groups

Arm 1 (Conventional treatment group)

Active Comparator group

Description:

Will 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

Treatment:

Drug: Rifampicin

Drug: Pyrazinamide

Drug: Ethambutol

Drug: Isoniazid

Arm 2 (High-dose rifampicin group)

Experimental group

Description:

High-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

Treatment:

Drug: Pyrazinamide

Drug: High-dose rifampicin

Drug: Isoniazid