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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High-dose rifampicin
  • Isoniazid
  • Pyrazinamide
  • Ethambutol
  • Rifampicin

Treatment groups

926 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

Chonnam National University Hospital

Collaborator

National Medical Center, Seoul

Collaborator

Pusan National University Hospital

Collaborator

Pusan National University Yangsan Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Severance Hospital

Collaborator

Korean Institute of Tuberculosis

Collaborator

International Tuberculosis Research Center

Collaborator

Korean Center for Disease Control and Prevention

Collaborator