Window Prophylaxis for Mycobacterium tuberculosis Infection Prevention in Child and Adolescent Household Contacts: Study Protocol for a Cluster-Randomized Controlled Trial (the TB-WIN trial)

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dc.catalogadorjlo
dc.contributor.authorLe Corre Pérez, Monique Nicole
dc.contributor.authorAllel, Kasim
dc.contributor.authorHernández, Mariluz
dc.contributor.authorEscobar, Nadia
dc.contributor.authorRuiz-tagle Seguel, Cinthya Grace
dc.contributor.authorValenzuela, Pablo
dc.contributor.authorBernales Silva, Margarita María
dc.contributor.authorGarcía Cañete, Patricia Del Carmen
dc.contributor.authorParedes Peñaloza, Fabio Ariel
dc.contributor.authorNathavitharana, Ruvandhi
dc.contributor.authorBronzic, Yasna
dc.contributor.authorBustamante, María Cecilia
dc.contributor.authorBarra, Sofia De la
dc.contributor.authorKreft, Javiera
dc.contributor.authorMadrid, Ricardo
dc.contributor.authorMadrid, Rossana
dc.contributor.authorMéndez, Mireya
dc.contributor.authorMery, Álvaro
dc.contributor.authorMeyer, Matías
dc.contributor.authorOviedo, Valeria
dc.contributor.authorPérez, María Eugenia
dc.contributor.authorPérez de Arce, Juan
dc.contributor.authorRamírez, Ana María
dc.contributor.authorRivas, Mabel
dc.contributor.authorRojas, Gladys
dc.contributor.authorBalcells Marty, María Elvira
dc.date.accessioned2026-01-20T19:41:49Z
dc.date.available2026-01-20T19:41:49Z
dc.date.issued2025
dc.description.abstractAbstract Trials guidance: The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections: Background : Mycobacterium tuberculosis acquisition after exposure is common but difficult to diagnose and frequently requires serial testing given that immunological evidence of infection can take several weeks to develop. Even though tuberculosis infection (TBI) is asymptomatic, its long-term effects remain unclear due to poorly understood host-pathogen interactions and delayed disease development, and research has shown that active mycobacterial replication and inflammation occur during TBI. Although the main purpose of antituberculosis prophylaxis has been to prevent people with established TBI from progressing to active tuberculosis disease, a few studies have suggested that this prophylaxis, when administered during the window period after exposure, can prevent the acquisition of TBI in very young children. Considering that newer preventive regimens are shorter and safer, this study aims to assess whether tuberculosis prophylaxis —when given in the window period after exposure— can prevent new infections in older children and adolescents who have been recently exposed. Methods : A multicentre cluster-randomized controlled clinical trial will be performed in Chile. A total of 360 households (clusters) with children aged ≥5 to <18 years, who have been recently exposed to a new case of pulmonary tuberculosis will be randomized to intervention or control arm. In the intervention arm, contacts will receive immediate tuberculosis prophylaxis, regardless of the interferon-gamma release assay (IGRA) result. In the control arm, participants will receive tuberculosis prophylaxis only if the IGRA test results positive, as per standard of care. In both arms, the prophylaxis scheme will be the usual weekly isoniazid plus rifapentine for 12 weeks regimen. The primary outcome will be assessed at the individual level by IGRA conversions from negative at baseline to positive at the 12-week follow-up. Discussion : This trial will establish the effectiveness of a window prophylaxis strategy in reducing the risk of TBI acquisition after exposure in a community setting, a strategy that can potentially contribute to global tuberculosis elimination by reducing M. tuberculosis reservoirs. Trial registration : ClinicalTrials.gov, NCT07086820. Registered 17 July 2025, https://clinicaltrials.gov/study/NCT07086820.
dc.fechaingreso.objetodigital2026-01-20
dc.format.extent34 páginas
dc.fuente.origenORCID
dc.identifier.doi10.21203/rs.3.rs-7421527/v1
dc.identifier.urihttps://doi.org/10.21203/rs.3.rs-7421527/v1
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/107792
dc.information.autorucEscuela de Medicina; Valenzuela Garcia, Pablo Tomas; 0009-0001-2589-5424; 252774
dc.information.autorucFacultad de Ciencias Biológicas; Le Corre Pérez, Monique Nicole; 0000-0002-9361-4049; 6737
dc.information.autorucEscuela de Medicina; Ruiz-tagle Seguel, Cinthya Grace; S/I; 1098594
dc.information.autorucEscuela de Enfermería; Bernales Silva, Margarita María; 0000-0002-4993-8927; 16724
dc.information.autorucEscuela de Medicina; García Cañete, Patricia Del Carmen; 0000-0002-5983-2392; 73909
dc.information.autorucEscuela de Medicina; Paredes Peñaloza, Fabio Ariel; S/I; 250592
dc.information.autorucEscuela de Medicina; Balcells Marty, María Elvira; 0000-0002-7223-9665; 7462
dc.language.isoen
dc.nota.accesocontenido completo
dc.revistaResearch Square
dc.rightsacceso abierto
dc.subjectTuberculosis
dc.subjectMycobacterium tuberculosis infection
dc.subjectWindow prophylaxis
dc.subjectChemoprophylaxis
dc.subjectHousehold contacts
dc.subject.ddc610
dc.titleWindow Prophylaxis for Mycobacterium tuberculosis Infection Prevention in Child and Adolescent Household Contacts: Study Protocol for a Cluster-Randomized Controlled Trial (the TB-WIN trial)
dc.typepreprint
sipa.codpersvinculados252774
sipa.codpersvinculados6737
sipa.codpersvinculados1098594
sipa.codpersvinculados16724
sipa.codpersvinculados73909
sipa.codpersvinculados250592
sipa.codpersvinculados7462
sipa.trazabilidadORCID;2026-01-19
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