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

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.

Conditions

• Tuberculosis, Pulmonary

Interventions

DRUG

High-dose rifampicin

30mg/kg

DRUG

Isoniazid

300mg

DRUG

Pyrazinamide

20-30mg/kg

DRUG

Ethambutol

15-20mg/kg

DRUG

Rifampicin

10mg/kg

Sponsors & Collaborators

• Chonnam National University Hospital

  collaborator OTHER

• National Medical Center, Seoul

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Pusan National University Yangsan Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Korean Institute of Tuberculosis

  collaborator OTHER

• International Tuberculosis Research Center

  collaborator OTHER

• Korean Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Seoul National University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-30

Primary Completion

2025-08-31

Completion

2026-12-31

Countries

• South Korea

Study Locations