[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":39,"locations":49,"responsibleParty":224,"collaborators":38,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":228,"sex":234,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":38,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":251,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care tuberculosis prophylaxis","ACTIVE_COMPARATOR","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.",[13],"Drug: Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks",{"label":15,"type":16,"description":17,"interventionNames":18},"Window tuberculosis prophylaxis","EXPERIMENTAL","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.",[19],"Drug: Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks","Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants.",[15],[27,28,29],"Window prophylaxis","Window period tuberculosis prophylaxis","Universal tuberculosis prophylaxis",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks","Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline.",[9],[35,36,37],"Tuberculosis prophylaxis","Chemoprophylaxis","Tuberculosis preventive treatment (TPT)",null,[40,45],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"María Elvira Balcells, MD","CONTACT","+56 955043508","ebalcells@uc.cl",{"name":46,"role":42,"phone":47,"phoneExt":38,"email":48},"Nicole Le Corre, MD","+56 223546823","mlec@uc.cl",[50,69,84,97,111,124,137,150,163,173,183,197,211],{"facility":51,"status":52,"city":53,"state":54,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Hospital Dr. Carlos Cisterna","RECRUITING","Calama","Antofagasta","Chile","CL",{"type":58,"coordinates":59},"Point",[60,61],-68.92371,-22.45667,{"lat":61,"lon":60},[64,67],{"name":65,"role":42,"phone":38,"phoneExt":38,"email":66},"Álvaro Mery, MD","alvaro.mery@redsalud.gob.cl",{"name":65,"role":68,"phone":38,"phoneExt":38,"email":38},"PRINCIPAL_INVESTIGATOR",{"facility":70,"status":71,"city":72,"state":73,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Hospital de Coquimbo","NOT_YET_RECRUITING","Coquimbo","Coquimbo Region",{"type":58,"coordinates":75},[76,77],-71.33947,-29.95332,{"lat":77,"lon":76},[80,83],{"name":81,"role":42,"phone":38,"phoneExt":38,"email":82},"Yasna Bronzic, MD","y.bronzic@gmail.com",{"name":81,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":85,"status":71,"city":86,"state":73,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital San Juan de Dios de La Serena","La Serena",{"type":58,"coordinates":88},[89,90],-71.25014,-29.90591,{"lat":90,"lon":89},[93,96],{"name":94,"role":42,"phone":38,"phoneExt":38,"email":95},"Arlette Andrade, MD","dra.arletteandrade@gmail.com",{"name":94,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":98,"status":71,"city":99,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital de Niños Roberto del Río","Independencia","Santiago Metropolitan",{"type":58,"coordinates":102},[103,104],-70.66647,-33.41167,{"lat":104,"lon":103},[107,110],{"name":108,"role":42,"phone":38,"phoneExt":38,"email":109},"Javiera Kreft, MD","javierakreft@gmail.com",{"name":108,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":112,"status":71,"city":113,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Hospital Luis Calvo Mackenna","Providencia",{"type":58,"coordinates":115},[116,117],-70.60454,-33.43107,{"lat":117,"lon":116},[120,123],{"name":121,"role":42,"phone":38,"phoneExt":38,"email":122},"Matías Meyer, MD","mmeyer@calvomackenna.cl",{"name":121,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":125,"status":52,"city":126,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Complejo Asistencial Dr. Sótero Del Río","Puente Alto",{"type":58,"coordinates":128},[129,130],-70.57577,-33.61169,{"lat":130,"lon":129},[133,136],{"name":134,"role":42,"phone":38,"phoneExt":38,"email":135},"Ricardo Madrid, MD","ricardomadridh@gmail.com",{"name":134,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":138,"status":52,"city":139,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Hospital CRS El Pino","San Bernardo",{"type":58,"coordinates":141},[142,143],-70.6996,-33.59217,{"lat":143,"lon":142},[146,149],{"name":147,"role":42,"phone":38,"phoneExt":38,"email":148},"Gladys Rojas, MD","gladys.rojas@usach.cl",{"name":147,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":151,"status":52,"city":152,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Hospital Clínico Félix Bulnes","Santiago",{"type":58,"coordinates":154},[155,156],-70.64827,-33.45694,{"lat":156,"lon":155},[159,162],{"name":160,"role":42,"phone":38,"phoneExt":38,"email":161},"María Cecilia Bustamante, MD","mcecilia.bustamante@redsalud.gob.cl",{"name":160,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":164,"status":52,"city":152,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":165,"geoPoint":167,"contacts":168},"Hospital Clínico San Borja Arriarán",{"type":58,"coordinates":166},[155,156],{"lat":156,"lon":155},[169,172],{"name":170,"role":42,"phone":38,"phoneExt":38,"email":171},"Mabel Rivas, MD","mabelrivas@gmail.com",{"name":170,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":174,"status":71,"city":152,"state":100,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Hospital San Juan de Dios de Santiago",{"type":58,"coordinates":176},[155,156],{"lat":156,"lon":155},[179,182],{"name":180,"role":42,"phone":38,"phoneExt":38,"email":181},"Ana María Ramírez, MD","amramirezq@gmail.com",{"name":180,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":184,"status":71,"city":185,"state":186,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Hospital Alto Hospicio","Alto Hospicio","Tarapacá",{"type":58,"coordinates":188},[189,190],-70.1049,-20.26871,{"lat":190,"lon":189},[193,196],{"name":194,"role":42,"phone":38,"phoneExt":38,"email":195},"Sofía De la Barra, MD","sofia.delabarra@hah.gob.cl",{"name":194,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":198,"status":71,"city":199,"state":200,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Hospital Claudio Vicuña","San Antonio","Valparaiso",{"type":58,"coordinates":202},[203,204],-71.60746,-33.59473,{"lat":204,"lon":203},[207,210],{"name":208,"role":42,"phone":38,"phoneExt":38,"email":209},"Rossana Madrid, MD","rossana.madridm@gmail.com",{"name":208,"role":68,"phone":38,"phoneExt":38,"email":38},{"facility":212,"status":71,"city":213,"state":200,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Hospital Dr. Gustavo Fricke","Viña del Mar",{"type":58,"coordinates":215},[216,217],-71.55183,-33.02457,{"lat":217,"lon":216},[220,223],{"name":221,"role":42,"phone":38,"phoneExt":38,"email":222},"María Eugenia Pérez, MD","meperezo64@gmail.com",{"name":221,"role":68,"phone":38,"phoneExt":38,"email":38},{"type":68,"investigatorFullName":41,"investigatorTitle":225,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Associate Professor","100599617","window-prophylaxis-for-pediatric-tuberculosis-prevention-trial-100599617",false,"NCT07086820","Window Prophylaxis for Pediatric Tuberculosis Prevention Trial","Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial","TB-WIN","Inclusion Criteria:\n\n* Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis\n* Age ≥5 to \\\u003C18 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","ALL","5 Years","17 Years",{"count":238,"type":239},647,"ESTIMATED","INTERVENTIONAL",[242],"NA","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.",[245,246,247,248,249,250],"Tuberculosis Infection","Household Contacts","Children","Adolescent","Tuberculosis Infection, Latent","Tuberculosis",[252,253,254,255,247,248,256,250,257],"Household contacts","Prophylaxis","Tuberculosis infection","Mycobacterium tuberculosis","Randomized clinical trial","Cluster-randomized trial","2025-12-20",{"date":260,"type":261},"2025-12-29","ACTUAL",{"date":263,"type":261},"2025-10-27",{"date":265,"type":239},"2028-11",{"name":5,"class":6},13]