Status:
NOT_YET_RECRUITING
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Chonnam National University Hospital
National Medical Center, Seoul
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
19-85 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
926 Patients enrolled
Trial Details
Trial ID
NCT04485156
Start Date
September 1 2020
End Date
December 1 2026
Last Update
July 24 2020
Active Locations (1)
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1
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, South Korea, 110-744