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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485156
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
Chonnam National University Hospital
National Medical Center, Seoul
Pusan National University Hospital
Pusan National University Yangsan Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Severance Hospital
Korean Institute of Tuberculosis
International Tuberculosis Research Center
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Drug: High-dose rifampicin Drug: Isoniazid Drug: Pyrazinamide Drug: Ethambutol Drug: Rifampicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Rifampin

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

Drug: Isoniazid
300mg

Drug: Pyrazinamide
20-30mg/kg

Drug: Ethambutol
15-20mg/kg

Drug: Rifampicin
10mg/kg

Experimental: Arm 2 (High-dose rifampicin group)

High-dose rifampicin, isoniazid, and pyrazinamide

  • Rifampicin: 30mg/kg
  • Isoniazid: 300mg/day
  • Pyrazinamide: 1000mg/day (<50kg), 1500mg/day (50-70kg), 2000mg /day (>70kg), till culture conversion Duration of the treatment
  • Till 12 weeks after culture conversion on liquid media
Drug: High-dose rifampicin
30mg/kg

Drug: Isoniazid
300mg

Drug: Pyrazinamide
20-30mg/kg




Primary Outcome Measures :
  1. Incidence of unfavorable treatment outcomes between two arms [ Time Frame: Within 18 months of randomization ]

Secondary Outcome Measures :
  1. Time to unfavorable treatment outcomes [ Time Frame: Within 18 months of randomization ]
  2. Time to culture conversion on liquid media [ Time Frame: Censored at 2 months of treatment ]
  3. Proportion of participants with treatment success [ Time Frame: At the end of treatment ]
  4. Proportion of participants with relapse of same strain [ Time Frame: At the end of study ]
  5. Time to relapse with same strain [ Time Frame: through study completion, 18months after randomization ]
  6. Occurrence of AEs grade 3 and above [ Time Frame: through study completion, 18months after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485156


Locations
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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, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Chonnam National University Hospital
National Medical Center, Seoul
Pusan National University Hospital
Pusan National University Yangsan Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Severance Hospital
Korean Institute of Tuberculosis
International Tuberculosis Research Center
Korean Center for Disease Control and Prevention
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04485156    
Other Study ID Numbers: Hi-DoRi-3
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
Tuberculosis
Rifampicin
Treatment
Shortening
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Isoniazid
Rifampin
Pyrazinamide
Ethambutol
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antibiotics, Antitubercular
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers