Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT07086820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}, {'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': 'D000085343', 'term': 'Latent Infection'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D018890', 'term': 'Chemoprevention'}], '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'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multicenter, controlled, cluster-randomized, open-label, superiority trial. A total of 360 households (clusters), each with at least one child aged ≥5 to \\<18 years and recently exposed to a new case of pulmonary tuberculosis within the household, will be randomly assigned in a 1:1 allocation ratio to either the intervention or control arm.\n\nThe intervention consists of a window prophylaxis strategy, while the control involves prophylaxis only for participants with confirmed M. tuberculosis infection.\n\nTo ensure early enrollment, households will be eligible only if the tuberculosis index patient has received no more than 15 daily doses of antituberculous treatment, for both study arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 647}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of new tuberculosis infections (all IGRA conversions) from enrollment until the end of follow-up in both study arms', 'timeFrame': 'At the end of follow-up at 12 weeks (accepted range: ≥ 12 - ≤16 weeks)'}], 'secondaryOutcomes': [{'measure': 'Incidence of new tuberculosis infections (IGRA conversions) with high IGRA thresholds (IFN-γ ≥1.0 IU/mL) at the end of follow-up in both study arms', 'timeFrame': 'At the end of follow-up at 12 weeks (accepted range ≥12 - ≤16 weeks)'}, {'measure': 'Incidence of active tuberculosis development until the end of follow-up in both study arms', 'timeFrame': 'From 4 weeks after enrollment to the end of follow-up at 12 weeks (accepted range ≥ 4 - ≤16 weeks)'}, {'measure': 'Prevalence of tuberculosis infections (all IGRA positive) at the end of follow-up in both study arms.', 'timeFrame': 'At the end of follow-up at 12 weeks (accepted range ≥ 12 - ≤16 weeks)'}, {'measure': 'Incidence of 3HP-related adverse events at 12 weeks in both study arms', 'timeFrame': 'From TPT initiation to completion or last dose received, in both study arms (accepted range ≥ 1 day - ≤16 weeks)'}, {'measure': 'To evaluate temporal changes in IFN-γ levels between baseline and follow-up among individuals receiving or not receiving tuberculosis preventive treatment', 'timeFrame': 'At the end of follow-up at 12 weeks (accepted range: ≥ 12 - ≤16 weeks)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Household contacts', 'Prophylaxis', 'Tuberculosis infection', 'Mycobacterium tuberculosis', 'Children', 'Adolescent', 'Randomized clinical trial', 'Tuberculosis', 'Cluster-randomized trial'], 'conditions': ['Tuberculosis Infection', 'Household Contacts', 'Children', 'Adolescent', 'Tuberculosis Infection, Latent', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The goal of this cluster-randomized controlled trial is to evaluate the effectiveness of tuberculosis preventive treatment (TPT) administered during the "window period" to prevent new Mycobacterium tuberculosis infections in children and adolescents.\n\nThe main question it aims to answer is:\n\nCan immediate TPT reduce the incidence of IGRA conversions in children and adolescents who are household contacts of a newly diagnosed pulmonary tuberculosis patient?\n\nResearchers will compare the incidence of new tuberculosis infections-measured by IGRA conversion at 12 weeks-between participants who receive immediate TPT while still uninfected (baseline IGRA-negative) and those who receive standard care, in which TPT is not offered to IGRA-negative contacts.\n\nParticipants will be:\n\n1. Tested for M. tuberculosis infection using the Interferon-Gamma Release Assay (IGRA), specifically the QuantiFERON-TB Gold Plus, at enrollment and after 12 weeks of follow-up.\n2. Take weekly isoniazid and rifapentine for 12 weeks if:\n\n 1. They are assigned to the intervention arm (regardless of baseline IGRA result), or\n 2. They are in the control arm and test IGRA-positive at baseline.\n\nAdditionally, participants from the control arm who experience an IGRA conversion at 12 weeks (following the primary outcome assessment) will also receive TPT, as per standard of care.', 'detailedDescription': 'Mycobacterium tuberculosis acquisition following exposure is a common occurrence, but it remains challenging to diagnose, often requiring serial testing, as immunological responses (e.g., tuberculin skin test or interferon-gamma release assays) can take weeks to provide evidence of infection. Although tuberculosis infection is generally asymptomatic, research has shown that active mycobacterial replication and inflammation occur, and its long-term effects are not well understood due to the complexity of host-pathogen interactions and delayed disease progression. While antituberculosis prophylaxis has traditionally aimed at preventing the progression from established tuberculosis infection to active tuberculosis disease, recent studies suggest that prophylaxis administered during the "window period" after exposure may also prevent its acquisition, particularly in very young children.\n\nThis trial will help determine the effectiveness of tuberculosis prophylaxis administered during the window period in preventing the acquisition of tuberculosis infection in children and adolescents exposed in household settings. If successful, the findings may inform broader strategies for tuberculosis prevention, particularly in reducing reservoirs of Mycobacterium tuberculosis and contributing to the global tuberculosis elimination efforts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis\n* Age ≥5 to \\<18 years old\n\nExclusion Criteria:\n\n* Suspected active tuberculosis in initial assessment (clinical or radiological)\n* Current pregnancy or breastfeeding\n* Immunocompromised\n* Allergy or contraindication to isoniazid or rifapentine\n* Chronic liver disease or alcohol use disorder\n* History of previous treatment for active or latent tuberculosis infection\n* Previous tuberculin skin test\n* Household contacts of a tuberculosis index patient with a known or suspected drug-resistant M. tuberculosis strain\n* Household contacts or a tuberculosis index patient currently living away from home for more than four weeks\n* Household contacts of a tuberculosis index patient who have already received more than 15 daily doses of antituberculous treatment'}, 'identificationModule': {'nctId': 'NCT07086820', 'acronym': 'TB-WIN', 'briefTitle': 'Window Prophylaxis for Pediatric Tuberculosis Prevention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '240519001'}, 'secondaryIdInfos': [{'id': 'FONDECYT N° 1250853', 'type': 'OTHER_GRANT', 'domain': 'Agencia Nacional de Investigación y Desarrollo de Chile (ANID)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care tuberculosis prophylaxis', 'description': 'In the Control Arm, only participants with a positive baseline IGRA result will receive tuberculosis preventive treatment (TPT). Therefore, TPT will not be given to participants with a negative baseline IGRA result at enrollment.', 'interventionNames': ['Drug: Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Window tuberculosis prophylaxis', 'description': 'In the Intervention Arm, all participants will be immediately prescribed tuberculosis preventive treatment (TPT), irrespective of their baseline IGRA result. Therefore, TPT will be given to participants having either positive or negative baseline IGRA results at enrollment.', 'interventionNames': ['Drug: Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks']}], 'interventions': [{'name': 'Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks', 'type': 'DRUG', 'otherNames': ['Window prophylaxis', 'Window period tuberculosis prophylaxis', 'Universal tuberculosis prophylaxis'], 'description': 'Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants.', 'armGroupLabels': ['Window tuberculosis prophylaxis']}, {'name': 'Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks', 'type': 'DRUG', 'otherNames': ['Tuberculosis prophylaxis', 'Chemoprophylaxis', 'Tuberculosis preventive treatment (TPT)'], 'description': 'Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline.', 'armGroupLabels': ['Standard of care tuberculosis prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calama', 'state': 'Antofagasta', 'country': 'Chile', 'contacts': [{'name': 'Álvaro Mery, MD', 'role': 'CONTACT', 'email': 'alvaro.mery@redsalud.gob.cl'}, {'name': 'Álvaro Mery, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Dr. Carlos Cisterna', 'geoPoint': {'lat': -22.45667, 'lon': -68.92371}}, {'city': 'Coquimbo', 'state': 'Coquimbo Region', 'country': 'Chile', 'contacts': [{'name': 'Yasna Bronzic, MD', 'role': 'CONTACT', 'email': 'y.bronzic@gmail.com'}, {'name': 'Yasna Bronzic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Coquimbo', 'geoPoint': {'lat': -29.95332, 'lon': -71.33947}}, {'city': 'La Serena', 'state': 'Coquimbo Region', 'country': 'Chile', 'contacts': [{'name': 'Arlette Andrade, MD', 'role': 'CONTACT', 'email': 'dra.arletteandrade@gmail.com'}, {'name': 'Arlette Andrade, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital San Juan de Dios de La Serena', 'geoPoint': {'lat': -29.90591, 'lon': -71.25014}}, {'city': 'San Antonio', 'state': 'Región de Valparaíso', 'country': 'Chile', 'contacts': [{'name': 'Rossana Madrid, MD', 'role': 'CONTACT', 'email': 'rossana.madridm@gmail.com'}, {'name': 'Rossana Madrid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Claudio Vicuña', 'geoPoint': {'lat': -33.59473, 'lon': -71.60746}}, {'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'contacts': [{'name': 'María Eugenia Pérez, MD', 'role': 'CONTACT', 'email': 'meperezo64@gmail.com'}, {'name': 'María Eugenia Pérez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Dr. Gustavo Fricke', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'city': 'Independencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Javiera Kreft, MD', 'role': 'CONTACT', 'email': 'javierakreft@gmail.com'}, {'name': 'Javiera Kreft, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Niños Roberto del Río', 'geoPoint': {'lat': -33.41167, 'lon': -70.66647}}, {'city': 'Providencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Matías Meyer, MD', 'role': 'CONTACT', 'email': 'mmeyer@calvomackenna.cl'}, {'name': 'Matías Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Luis Calvo Mackenna', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'Puente Alto', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Ricardo Madrid, MD', 'role': 'CONTACT', 'email': 'ricardomadridh@gmail.com'}, {'name': 'Ricardo Madrid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Asistencial Dr. Sótero Del Río', 'geoPoint': {'lat': -33.61169, 'lon': -70.57577}}, {'city': 'San Bernardo', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Belkys Rueda, MD', 'role': 'CONTACT', 'email': 'belkysrue@hotmail.com'}, {'name': 'Belkys Rueda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital El Pino', 'geoPoint': {'lat': -33.59217, 'lon': -70.6996}}, {'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'María Cecilia Bustamante, MD', 'role': 'CONTACT', 'email': 'mcecilia.bustamante@redsalud.gob.cl'}, {'name': 'María Cecilia Bustamante, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Félix Bulnes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Mabel Rivas, MD', 'role': 'CONTACT', 'email': 'mabelrivas@gmail.com'}, {'name': 'Mabel Rivas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico San Borja Arriarán', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Ana María Ramírez, MD', 'role': 'CONTACT', 'email': 'amramirezq@gmail.com'}, {'name': 'Ana María Ramírez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital San Juan de Dios de Santiago', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Alto Hospicio', 'state': 'Tarapacá', 'country': 'Chile', 'contacts': [{'name': 'Sofía De la Barra, MD', 'role': 'CONTACT', 'email': 'sofia.delabarra@hah.gob.cl'}, {'name': 'Sofía De la Barra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Alto Hospicio', 'geoPoint': {'lat': -20.26871, 'lon': -70.1049}}], 'centralContacts': [{'name': 'María Elvira Balcells, MD', 'role': 'CONTACT', 'email': 'ebalcells@uc.cl', 'phone': '+56 955043508'}, {'name': 'Nicole Le Corre, MD', 'role': 'CONTACT', 'email': 'mlec@uc.cl', 'phone': '+56 223546823'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'María Elvira Balcells, MD', 'investigatorAffiliation': 'Pontificia Universidad Catolica de Chile'}}}}