- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485156
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3) (Hi-DoRi-3)
July 21, 2020 updated by: Seoul National University Hospital
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
926
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1 (Conventional treatment group)
Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment - 6 months in total |
300mg
20-30mg/kg
15-20mg/kg
10mg/kg
|
Experimental: Arm 2 (High-dose rifampicin group)
High-dose rifampicin, isoniazid, and pyrazinamide
|
300mg
20-30mg/kg
30mg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of unfavorable treatment outcomes between two arms
Time Frame: Within 18 months of randomization
|
Within 18 months of randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to unfavorable treatment outcomes
Time Frame: Within 18 months of randomization
|
Within 18 months of randomization
|
Time to culture conversion on liquid media
Time Frame: Censored at 2 months of treatment
|
Censored at 2 months of treatment
|
Proportion of participants with treatment success
Time Frame: At the end of treatment
|
At the end of treatment
|
Proportion of participants with relapse of same strain
Time Frame: At the end of study
|
At the end of study
|
Time to relapse with same strain
Time Frame: through study completion, 18months after randomization
|
through study completion, 18months after randomization
|
Occurrence of AEs grade 3 and above
Time Frame: through study completion, 18months after randomization
|
through study completion, 18months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Fatty Acid Synthesis Inhibitors
- Rifampin
- Isoniazid
- Pyrazinamide
- Ethambutol
Other Study ID Numbers
- Hi-DoRi-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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