Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04485156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-07-24
First Post:
2020-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D011718', 'term': 'Pyrazinamide'}, {'id': 'D004977', 'term': 'Ethambutol'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 926}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of unfavorable treatment outcomes between two arms', 'timeFrame': 'Within 18 months of randomization'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Rifampicin', 'Treatment', 'Shortening'], 'conditions': ['Tuberculosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '39343425', 'type': 'DERIVED', 'citation': 'Kwak N, Kim JY, Kim HJ, Kwon BS, Lee JH, Mok J, Kwon YS, Kang YA, Park Y, Lee JY, Jeon D, Lee JK, Yang JS, Whang J, Kim KJ, Kim YR, Cheon M, Park J, Hahn S, Yim JJ. High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis. Tuberc Respir Dis (Seoul). 2025 Jan;88(1):170-180. doi: 10.4046/trd.2024.0099. Epub 2024 Sep 27.'}, {'pmid': '35978342', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented positivity by sputum Xpert MTB/RIF assay\n* Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.\n\nExclusion Criteria:\n\n* Negative on Xpert MTB/RIF assay\n* Resistance to rifampicin as detected by an Xpert MTB/RIF assay\n* Known resistance to isoniazid, rifampicin, or pyrazinamide\n* HIV positive\n* Cancer patient on anti-cancer chemotherapy\n* Uncontrolled DM\n* Chronic hepatitis, liver cirrhosis\n* Any contraindications of drugs to be used'}, 'identificationModule': {'nctId': 'NCT04485156', 'acronym': 'Hi-DoRi-3', 'briefTitle': 'Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Hi-DoRi-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 (Conventional treatment group)', 'description': '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\n\n\\- 6 months in total', 'interventionNames': ['Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol', 'Drug: Rifampicin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (High-dose rifampicin group)', 'description': 'High-dose rifampicin, isoniazid, and pyrazinamide\n\n* Rifampicin: 30mg/kg\n* Isoniazid: 300mg/day\n* Pyrazinamide: 1000mg/day (\\<50kg), 1500mg/day (50-70kg), 2000mg /day (\\>70kg), till culture conversion Duration of the treatment\n* Till 12 weeks after culture conversion on liquid media', 'interventionNames': ['Drug: High-dose rifampicin', 'Drug: Isoniazid', 'Drug: Pyrazinamide']}], 'interventions': [{'name': 'High-dose rifampicin', 'type': 'DRUG', 'description': '30mg/kg', 'armGroupLabels': ['Arm 2 (High-dose rifampicin group)']}, {'name': 'Isoniazid', 'type': 'DRUG', 'description': '300mg', 'armGroupLabels': ['Arm 1 (Conventional treatment group)', 'Arm 2 (High-dose rifampicin group)']}, {'name': 'Pyrazinamide', 'type': 'DRUG', 'description': '20-30mg/kg', 'armGroupLabels': ['Arm 1 (Conventional treatment group)', 'Arm 2 (High-dose rifampicin group)']}, {'name': 'Ethambutol', 'type': 'DRUG', 'description': '15-20mg/kg', 'armGroupLabels': ['Arm 1 (Conventional treatment group)']}, {'name': 'Rifampicin', 'type': 'DRUG', 'description': '10mg/kg', 'armGroupLabels': ['Arm 1 (Conventional treatment group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', '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', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'National Medical Center, Seoul', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Korean Institute of Tuberculosis', 'class': 'OTHER'}, {'name': 'International Tuberculosis Research Center', 'class': 'OTHER'}, {'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}