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

Tuberculosis, Pulmonary Clinical Trial

— Hi-DoRi-3  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04485156
• Other study ID #: Hi-DoRi-3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2020
• Est. completion date: December 2026

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 926
• Est. completion date: December 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• High-dose rifampicin
30mg/kg
• Isoniazid
300mg
• Pyrazinamide
20-30mg/kg
• Ethambutol
15-20mg/kg
• Rifampicin
10mg/kg

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (11)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chonnam National University Hospital, International Tuberculosis Research Center, Korean Center for Disease Control and Prevention, Korean Institute of Tuberculosis, National Medical Center, Seoul, Pusan National University Hospital, Pusan National University Yangsan Hospital, Seoul National University Bundang Hospital, Severance Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of unfavorable treatment outcomes between two arms		Within 18 months of randomization
Secondary	Time to unfavorable treatment outcomes		Within 18 months of randomization
Secondary	Time to culture conversion on liquid media		Censored at 2 months of treatment
Secondary	Proportion of participants with treatment success		At the end of treatment
Secondary	Proportion of participants with relapse of same strain		At the end of study
Secondary	Time to relapse with same strain		through study completion, 18months after randomization
Secondary	Occurrence of AEs grade 3 and above		through study completion, 18months after randomization