Clinical trial NCT04485156: Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Tuberculosis, Pulmonary
Keywords: Tuberculosis
Rifampicin
Treatment
Shortening
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Chonnam National University Hospital
name: National Medical Center, Seoul
name: Pusan National University Hospital
name: Pusan National University Yangsan Hospital
name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: Severance Hospital
name: Korean Institute of Tuberculosis
name: International Tuberculosis Research Center
name: Korean Center for Disease Control and Prevention
First posted: 2020-07-24
Enrollment: 926
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of drug-sensitive pulmonary tuberculosis.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of unfavorable treatment outcomes between two arms
timeFrame: Within 18 months of randomization
Secondary outcomes:
measure: Time to unfavorable treatment outcomes
timeFrame: Within 18 months of randomization
measure: Time to culture conversion on liquid media
timeFrame: Censored at 2 months of treatment
measure: Proportion of participants with treatment success
timeFrame: At the end of treatment
measure: Proportion of participants with relapse of same strain
timeFrame: At the end of study
measure: Time to relapse with same strain
timeFrame: through study completion, 18months after randomization
measure: Occurrence of AEs grade 3 and above
timeFrame: through study completion, 18months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
Study officials:
References:
citation: Kwak N, Jeon D, Park Y, Kang YA, Kim KJ, Kim YR, Kwon BS, Kwon YS, Kim HJ, Lee JH, Lee JY, Lee JK, Mok J, Cheon M, Park J, Hahn S, Yim JJ. Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial. Trials. 2022 Aug 17;23(1):666. doi: 10.1186/s13063-022-06631-z.