Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-16 @ 9:55 PM
Study NCT ID:
NCT02613169
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2015-09-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Infant TB Infection Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sylvial2@uw.edu', 'phone': '206-616-5978', 'title': 'Dr. Sylvia M. LaCourse', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected throughout the study, for two years, two months.', 'description': 'Adverse events include Grade ≥3 severe adverse events by DAIDS scale', 'eventGroups': [{'id': 'EG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 1, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'HIV infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Pneumonia/URTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Corrective surgery for spina bifida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Corrective surgery for cleft palate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Corrective surgery for encephalocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Burns', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mycobacterium Tuberculosis (MTB) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'OG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months post randomization', 'description': 'Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status', 'calculatePct': False, 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analysis 132 in Isoniazid (14 without endpoint and 4 discontinued) and 133 in No Isoniazid arm (9 without primary endpoint, 8 discontinued)'}, {'type': 'SECONDARY', 'title': 'Severe Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'OG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with grade 3 or higher treatment-related adverse events as assessed by DAIDS Table for the Grading Severity of Pediatric Adverse Experiences', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined Outcome of MTB Infection, TB Disease, and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'OG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with a combined endpoint of MTB infection, TB disease, and death\n\n* MTB infection as measured by IGRA or tuberculin skin test at 12 months post-enrollment\n* TB disease including microbiologically confirmed (culture or Xpert positive), or probable TB (clinical diagnosis).\n* Death of infant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with MTB infection as measured by\n\n* IGRA, or\n* Tuberculin skin test (\\>10 mm) at 12 months post-enrollment, or\n* Interferon-gamma-independent immune markers in QFT-Plus supernatants\n\nCombined outcome will be defined as positive if IGRA OR TST OR interferon-gamma-independent marker is positive and combined outcome will be defined as negative if none of these is positive (if children do not have all three markers the definition will hold for available markers).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'OG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months post randomization', 'description': 'Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status', 'unitOfMeasure': 'TB infections/100 person years', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'FG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'HIV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No TB infection endpoint', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.\n\nIsoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.'}, {'id': 'BG001', 'title': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'BG000', 'lowerLimit': '6.0', 'upperLimit': '6.6'}, {'value': '6.3', 'groupId': 'BG001', 'lowerLimit': '6.0', 'upperLimit': '6.4'}, {'value': '6.3', 'groupId': 'BG002', 'lowerLimit': '6.0', 'upperLimit': '6.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 2301240, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-12T18:18', 'hasProtocol': True}, {'date': '2019-10-22', 'size': 646802, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-12T18:22', 'hasProtocol': False}, {'date': '2017-08-11', 'size': 288197, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-12T18:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2015-09-16', 'resultsFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-15', 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mycobacterium Tuberculosis (MTB) Infection', 'timeFrame': 'at 12 months post randomization', 'description': 'Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status'}, {'measure': 'Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence', 'timeFrame': 'at 12 months post randomization', 'description': 'Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status'}], 'secondaryOutcomes': [{'measure': 'Severe Adverse Events (SAE)', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with grade 3 or higher treatment-related adverse events as assessed by DAIDS Table for the Grading Severity of Pediatric Adverse Experiences'}, {'measure': 'Combined Outcome of MTB Infection, TB Disease, and Death', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with a combined endpoint of MTB infection, TB disease, and death\n\n* MTB infection as measured by IGRA or tuberculin skin test at 12 months post-enrollment\n* TB disease including microbiologically confirmed (culture or Xpert positive), or probable TB (clinical diagnosis).\n* Death of infant'}, {'measure': 'Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants', 'timeFrame': 'Over 12 months after randomization', 'description': 'Number of infants with MTB infection as measured by\n\n* IGRA, or\n* Tuberculin skin test (\\>10 mm) at 12 months post-enrollment, or\n* Interferon-gamma-independent immune markers in QFT-Plus supernatants\n\nCombined outcome will be defined as positive if IGRA OR TST OR interferon-gamma-independent marker is positive and combined outcome will be defined as negative if none of these is positive (if children do not have all three markers the definition will hold for available markers).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['M. tuberculosis infection', 'isoniazid', 'HIV-exposed infants'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '17085459', 'type': 'BACKGROUND', 'citation': 'Zar HJ, Cotton MF, Strauss S, Karpakis J, Hussey G, Schaaf HS, Rabie H, Lombard CJ. Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial. BMJ. 2007 Jan 20;334(7585):136. doi: 10.1136/bmj.39000.486400.55. Epub 2006 Nov 3.'}, {'pmid': '21732834', 'type': 'BACKGROUND', 'citation': 'Madhi SA, Nachman S, Violari A, Kim S, Cotton MF, Bobat R, Jean-Philippe P, McSherry G, Mitchell C; P1041 Study Team. Primary isoniazid prophylaxis against tuberculosis in HIV-exposed children. N Engl J Med. 2011 Jul 7;365(1):21-31. doi: 10.1056/NEJMoa1011214.'}, {'pmid': '35607710', 'type': 'RESULT', 'citation': 'LaCourse SM, Escudero JN, Mecha J, Warr AJ, Richardson BA, Carimo N, Cranmer LM, Maleche-Obimbo E, Matemo D, Kinuthia J, Hawn TR, John-Stewart G. Cumulative Mycobacterium tuberculosis Infection Incidence (Measured Primarily by Tuberculin Skin Test) Among Infants With Human Immunodeficiency Virus Exposure: Observational Follow-up of an Isoniazid Prophylaxis Trial. Clin Infect Dis. 2022 Dec 19;75(12):2253-2256. doi: 10.1093/cid/ciac393.'}, {'pmid': '32564076', 'type': 'DERIVED', 'citation': 'LaCourse SM, Richardson BA, Kinuthia J, Warr AJ, Maleche-Obimbo E, Matemo D, Cranmer LM, Mecha J, Escudero JN, Hawn TR, John-Stewart G. A Randomized Controlled Trial of Isoniazid to Prevent Mycobacterium tuberculosis Infection in Kenyan Human Immunodeficiency Virus-Exposed Uninfected Infants. Clin Infect Dis. 2021 Jul 15;73(2):e337-e344. doi: 10.1093/cid/ciaa827.'}, {'pmid': '31969368', 'type': 'DERIVED', 'citation': 'LaCourse SM, Richardson BA, Kinuthia J, Warr AJ, Maleche-Obimbo E, Matemo D, Cranmer LM, Escudero JN, Hawn TR, John-Stewart GC. Infant TB Infection Prevention Study (iTIPS): a randomised trial protocol evaluating isoniazid to prevent M. tuberculosis infection in HIV-exposed uninfected children. BMJ Open. 2020 Jan 21;10(1):e034308. doi: 10.1136/bmjopen-2019-034308.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.', 'detailedDescription': 'The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV exposed infants\n* Aged 6 weeks within (+ 4 weeks)\n* Born to HIV-infected mothers\n* Not premature and over 2.5 kg\n\nExclusion Criteria:\n\n* Infants with known exposure to active TB in household\n* Premature and \\< 2.5 kg'}, 'identificationModule': {'nctId': 'NCT02613169', 'acronym': 'iTIPS', 'briefTitle': 'Infant TB Infection Prevention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants', 'orgStudyIdInfo': {'id': 'STUDY00000341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isoniazid', 'description': 'Isoniazid (INH) \\~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.', 'interventionNames': ['Drug: Isoniazid']}, {'type': 'NO_INTERVENTION', 'label': 'No Isoniazid', 'description': 'No INH will be administered to this arm.'}], 'interventions': [{'name': 'Isoniazid', 'type': 'DRUG', 'otherNames': ['INH'], 'description': 'HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.', 'armGroupLabels': ['Isoniazid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Kisumu County Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Grace John-Stewart, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington, Dept of Global Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Global Health, Medicine, Epidemiology, Pediatrics', 'investigatorFullName': 'Grace John-Stewart', 'investigatorAffiliation': 'University of Washington'}}}}