Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05413551
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2022-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'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': 'D000085343', 'term': 'Latent Infection'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}], 'ancestors': [{'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isoniazid plasma area-under-the-curve', 'timeFrame': '1, 2, 8, and 24 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Maximum isoniazid concentration (Cmax)', 'timeFrame': '1, 2, 8, and 24 hours post-dose'}, {'measure': 'Isoniazid concentration at 24 hours', 'timeFrame': '24 hours post-dose'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis Infection', 'Isoniazid Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '34375564', 'type': 'BACKGROUND', 'citation': 'Verma R, Patil S, Zhang N, Moreira FMF, Vitorio MT, Santos ADS, Wallace E, Gnanashanmugam D, Persing DH, Savic RM, Croda J, Andrews JR. A Rapid Pharmacogenomic Assay to Detect NAT2 Polymorphisms and Guide Isoniazid Dosing for Tuberculosis Treatment. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1317-1326. doi: 10.1164/rccm.202103-0564OC.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eligible for latent tuberculosis treatment by Brazil's national guidelines\\*\n* provides written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Evidence of active tuberculosis or currently under evaluation for active tuberculosis\n* Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)\n* Known intolerance or hypersensitivity to isoniazid or rifapentine\n* Prior treatment for active or latent tuberculosis \\> 14 days\n* Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case\n* Neutropenia (absolute neutrophil count \\<1000 cells/mm3)\n* Clinical diagnosis of active liver disease or alcohol dependence\n* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 times the upper limit of normal"}, 'identificationModule': {'nctId': 'NCT05413551', 'briefTitle': 'Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention', 'orgStudyIdInfo': {'id': '65808'}, 'secondaryIdInfos': [{'id': '1R21AI172182-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AI172182-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid acetylator', 'description': 'Participants will receive 1 standard dose (Day 0), followed by 1 higher dose (Day 7), follow by 2 standard doses (Days 14 and 21).', 'interventionNames': ['Drug: Standard dose of isoniazid', 'Drug: High-dose isoniazid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermediate acetylator', 'description': 'Participants will receive 4 standard doses (Days 0, 7, 14 and 21).', 'interventionNames': ['Drug: Standard dose of isoniazid']}, {'type': 'EXPERIMENTAL', 'label': 'Slow acetylator', 'description': 'Participants will receive 2 standard doses (Days 0 and 7), followed by 1 lower dose (Day 21), follow by 1 standard dose (Day 21).', 'interventionNames': ['Drug: Low-dose isoniazid', 'Drug: Standard dose of isoniazid']}], 'interventions': [{'name': 'Low-dose isoniazid', 'type': 'DRUG', 'description': 'Pharmacogenomic-modified dose of isoniazid - 5 mg/kg oral tablet (maximum 300 mg)', 'armGroupLabels': ['Slow acetylator']}, {'name': 'Standard dose of isoniazid', 'type': 'DRUG', 'description': '15 mg/kg oral tablet (up to 900 mg)', 'armGroupLabels': ['Intermediate acetylator', 'Rapid acetylator', 'Slow acetylator']}, {'name': 'High-dose isoniazid', 'type': 'DRUG', 'description': 'Pharmacogenomic-modified dose of isoniazid - 25 mg/kg oral tablet (maximum 1500 mg)', 'armGroupLabels': ['Rapid acetylator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Federal University of Mato Grosso do Sul', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}], 'overallOfficials': [{'name': 'Jason R Andrews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'We will make the study protocol, statistical analysis plan, informed consent form and report available. We will make a de-identified dataset available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Federal University of Mato Grosso', 'class': 'OTHER'}, {'name': 'Fiocruz Mato Grosso do Sul', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Jason Andrews', 'investigatorAffiliation': 'Stanford University'}}}}