QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial

Background. Screening strategies based on interferon-y release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease. Methods. We conducted an open-label, randomized trial to test the noninferiority of a 2-step strategy with th...

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Autores: Munoz, L, Santin, M, Alcaide, F, Ruiz-Serrano, MJ, Gijon, P, Bermudez, E, Dominguez-Castellano, A, Navarro, MD, Ramirez, E, Perez-Escolano, E, Lopez-Prieto, MD, Gutierrez-Rodriguez, J, Anibarro, L, Calvino, L, Trigo, M, Cifuentes, C, Garcia-Gasalla, M, Payeras, A, Gasch, O, Espasa, M, Aguero, R, Ferrer, D, Cases, X, Gonzalez-Cuevas, A, Garcia-Zamalloa, A, Bikuna, E, Lecuona, M, Galindo, R, Ramirez-Lapausa, M, Carrillo, R
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p3924
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/3924
Access Level:acceso abierto
Palabra clave:interferon-gamma release assays
tuberculin skin test
preventive therapy
latent tuberculosis infection
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spelling QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical TrialMunoz, LSantin, MAlcaide, FRuiz-Serrano, MJGijon, PBermudez, EDominguez-Castellano, ANavarro, MDRamirez, EPerez-Escolano, ELopez-Prieto, MDGutierrez-Rodriguez, JAnibarro, LCalvino, LTrigo, MCifuentes, CGarcia-Gasalla, MPayeras, AGasch, OEspasa, MAguero, RFerrer, DCases, XGonzalez-Cuevas, AGarcia-Zamalloa, ABikuna, ELecuona, MGalindo, RRamirez-Lapausa, MCarrillo, Rinterferon-gamma release assaystuberculin skin testpreventive therapylatent tuberculosis infectionBackground. Screening strategies based on interferon-y release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease. Methods. We conducted an open-label, randomized trial to test the noninferiority of a 2-step strategy with the tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-GIT) as a confirmatory test (the TST/QFT arm) to the standard TST-alone strategy (TST arm) for targeting preventive therapy in household contacts of patients with tuberculosis. Participants were followed for 24 months after randomization. The primary endpoint was the development of tuberculosis, with a noninferiority margin of 1.5 percentage points. Results. A total of 871 contacts were randomized. Four contacts in the TST arm and 2 in the TST/QFT arm developed tuberculosis. In the modified intention-to-treat analysis, this accounted for 0.99% in the TST arm and 0.51% in the TST/QFT arm (-0.48% difference; 97.5% confidence interval [CI], -1.86% to 0.90%); in the per-protocol analysis, the corresponding rates were 1.67% and 0.82% in the TST and TST/QFT arms, respectively (-0.85% difference; 97.5% CI, -3.14% to 1.43%). Of the 792 contacts analyzed, 65.3% in the TST arm and 42.2% in the TST/QFT arm were diagnosed with tuberculosis infection (23.1% difference; 95% CI, 16.4% to 30.0%). Conclusions. In low-incidence settings, screening household contacts with the TST and using QFT-GIT as a confirmatory test is not inferior to TST-alone for preventing active tuberculosis, allowing a safe reduction of preventive treatments.OXFORD UNIV PRESS INC2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/3924CLINICAL INFECTIOUS DISEASESISSN: 10584838ISSNe: 15376591reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p39242026-06-21T15:30:37Z
dc.title.none.fl_str_mv QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
title QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
spellingShingle QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
Munoz, L
interferon-gamma release assays
tuberculin skin test
preventive therapy
latent tuberculosis infection
title_short QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
title_full QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
title_fullStr QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
title_full_unstemmed QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
title_sort QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial
dc.creator.none.fl_str_mv Munoz, L
Santin, M
Alcaide, F
Ruiz-Serrano, MJ
Gijon, P
Bermudez, E
Dominguez-Castellano, A
Navarro, MD
Ramirez, E
Perez-Escolano, E
Lopez-Prieto, MD
Gutierrez-Rodriguez, J
Anibarro, L
Calvino, L
Trigo, M
Cifuentes, C
Garcia-Gasalla, M
Payeras, A
Gasch, O
Espasa, M
Aguero, R
Ferrer, D
Cases, X
Gonzalez-Cuevas, A
Garcia-Zamalloa, A
Bikuna, E
Lecuona, M
Galindo, R
Ramirez-Lapausa, M
Carrillo, R
author Munoz, L
author_facet Munoz, L
Santin, M
Alcaide, F
Ruiz-Serrano, MJ
Gijon, P
Bermudez, E
Dominguez-Castellano, A
Navarro, MD
Ramirez, E
Perez-Escolano, E
Lopez-Prieto, MD
Gutierrez-Rodriguez, J
Anibarro, L
Calvino, L
Trigo, M
Cifuentes, C
Garcia-Gasalla, M
Payeras, A
Gasch, O
Espasa, M
Aguero, R
Ferrer, D
Cases, X
Gonzalez-Cuevas, A
Garcia-Zamalloa, A
Bikuna, E
Lecuona, M
Galindo, R
Ramirez-Lapausa, M
Carrillo, R
author_role author
author2 Santin, M
Alcaide, F
Ruiz-Serrano, MJ
Gijon, P
Bermudez, E
Dominguez-Castellano, A
Navarro, MD
Ramirez, E
Perez-Escolano, E
Lopez-Prieto, MD
Gutierrez-Rodriguez, J
Anibarro, L
Calvino, L
Trigo, M
Cifuentes, C
Garcia-Gasalla, M
Payeras, A
Gasch, O
Espasa, M
Aguero, R
Ferrer, D
Cases, X
Gonzalez-Cuevas, A
Garcia-Zamalloa, A
Bikuna, E
Lecuona, M
Galindo, R
Ramirez-Lapausa, M
Carrillo, R
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv interferon-gamma release assays
tuberculin skin test
preventive therapy
latent tuberculosis infection
topic interferon-gamma release assays
tuberculin skin test
preventive therapy
latent tuberculosis infection
description Background. Screening strategies based on interferon-y release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease. Methods. We conducted an open-label, randomized trial to test the noninferiority of a 2-step strategy with the tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-GIT) as a confirmatory test (the TST/QFT arm) to the standard TST-alone strategy (TST arm) for targeting preventive therapy in household contacts of patients with tuberculosis. Participants were followed for 24 months after randomization. The primary endpoint was the development of tuberculosis, with a noninferiority margin of 1.5 percentage points. Results. A total of 871 contacts were randomized. Four contacts in the TST arm and 2 in the TST/QFT arm developed tuberculosis. In the modified intention-to-treat analysis, this accounted for 0.99% in the TST arm and 0.51% in the TST/QFT arm (-0.48% difference; 97.5% confidence interval [CI], -1.86% to 0.90%); in the per-protocol analysis, the corresponding rates were 1.67% and 0.82% in the TST and TST/QFT arms, respectively (-0.85% difference; 97.5% CI, -3.14% to 1.43%). Of the 792 contacts analyzed, 65.3% in the TST arm and 42.2% in the TST/QFT arm were diagnosed with tuberculosis infection (23.1% difference; 95% CI, 16.4% to 30.0%). Conclusions. In low-incidence settings, screening household contacts with the TST and using QFT-GIT as a confirmatory test is not inferior to TST-alone for preventing active tuberculosis, allowing a safe reduction of preventive treatments.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://i3pt.portalinvestigacion.com/publicaciones/3924
url https://i3pt.portalinvestigacion.com/publicaciones/3924
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv OXFORD UNIV PRESS INC
publisher.none.fl_str_mv OXFORD UNIV PRESS INC
dc.source.none.fl_str_mv CLINICAL INFECTIOUS DISEASES
ISSN: 10584838
ISSNe: 15376591
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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