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

Last updated: July 21, 2020
Sponsor: Seoul National University Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT04485156
Hi-DoRi-3
  • Ages 19-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 926
Study Start date:
September 01, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

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