NCT04485156Not yet recruitingPhase 3
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Jul 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 926 (estimated)
- First submitted
- 6 Jul 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT04485156
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 926
- From 1 Sept 2020 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindications of drugs to be used
Other illness
- HIV positive
- Cancer patient on anti-cancer chemotherapy
- Chronic hepatitis, liver cirrhosis
Other
- Negative on Xpert MTB/RIF assay
- Resistance to rifampicin as detected by an Xpert MTB/RIF assay
- Known resistance to isoniazid, rifampicin, or pyrazinamide
- Uncontrolled DM
Who the study is looking for
- 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.
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.