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-? 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: Muñoz L, Santin M, Alcaide F, Ruíz-Serrano MJ, Gijón P, Bermúdez E, Domínguez-Castellano A, Navarro MD, Ramírez E, Pérez-Escolano E, López-Prieto MD, Gutiérrez-Rodriguez J, Anibarro L, Calviño L, Trigo M, Cifuentes C, García-Gasalla M, Payeras A, Gasch O, Espasa M, Agüero R, Ferrer D, Casas X, González-Cuevas A, García-Zamalloa A, Bikuña E, Lecuona M, Galindo R, Ramírez-Lapausa M, Carrillo R
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2018
País:España
Recursos:Fundació Sant Joan de Déu
Repositório:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p13081
Acesso em linha:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=13081
Access Level:Acceso aberto
Palavra-chave:*interferon-gamma release assays
*latent tuberculosis infection
*preventive therapy
*tuberculin skin test
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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 Trial.Muñoz LSantin MAlcaide FRuíz-Serrano MJGijón PBermúdez EDomínguez-Castellano ANavarro MDRamírez EPérez-Escolano ELópez-Prieto MDGutiérrez-Rodriguez JAnibarro LCalviño LTrigo MCifuentes CGarcía-Gasalla MPayeras AGasch OEspasa MAgüero RFerrer DCasas XGonzález-Cuevas AGarcía-Zamalloa ABikuña ELecuona MGalindo RRamírez-Lapausa MCarrillo R*interferon-gamma release assays*latent tuberculosis infection*preventive therapy*tuberculin skin testBACKGROUND: Screening strategies based on interferon-? 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. CLINICAL TRIALS REGISTRATION: NCT01223534.OXFORD UNIV PRESS INC2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=13081CLINICAL INFECTIOUS DISEASESISSN: 10584838ISSNe: 15376591reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p130812026-05-27T12:37:41Z
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.
Muñoz L
*interferon-gamma release assays
*latent tuberculosis infection
*preventive therapy
*tuberculin skin test
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 Muñoz L
Santin M
Alcaide F
Ruíz-Serrano MJ
Gijón P
Bermúdez E
Domínguez-Castellano A
Navarro MD
Ramírez E
Pérez-Escolano E
López-Prieto MD
Gutiérrez-Rodriguez J
Anibarro L
Calviño L
Trigo M
Cifuentes C
García-Gasalla M
Payeras A
Gasch O
Espasa M
Agüero R
Ferrer D
Casas X
González-Cuevas A
García-Zamalloa A
Bikuña E
Lecuona M
Galindo R
Ramírez-Lapausa M
Carrillo R
author Muñoz L
author_facet Muñoz L
Santin M
Alcaide F
Ruíz-Serrano MJ
Gijón P
Bermúdez E
Domínguez-Castellano A
Navarro MD
Ramírez E
Pérez-Escolano E
López-Prieto MD
Gutiérrez-Rodriguez J
Anibarro L
Calviño L
Trigo M
Cifuentes C
García-Gasalla M
Payeras A
Gasch O
Espasa M
Agüero R
Ferrer D
Casas X
González-Cuevas A
García-Zamalloa A
Bikuña E
Lecuona M
Galindo R
Ramírez-Lapausa M
Carrillo R
author_role author
author2 Santin M
Alcaide F
Ruíz-Serrano MJ
Gijón P
Bermúdez E
Domínguez-Castellano A
Navarro MD
Ramírez E
Pérez-Escolano E
López-Prieto MD
Gutiérrez-Rodriguez J
Anibarro L
Calviño L
Trigo M
Cifuentes C
García-Gasalla M
Payeras A
Gasch O
Espasa M
Agüero R
Ferrer D
Casas X
González-Cuevas A
García-Zamalloa A
Bikuña E
Lecuona M
Galindo R
Ramírez-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
*latent tuberculosis infection
*preventive therapy
*tuberculin skin test
topic *interferon-gamma release assays
*latent tuberculosis infection
*preventive therapy
*tuberculin skin test
description BACKGROUND: Screening strategies based on interferon-? 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. CLINICAL TRIALS REGISTRATION: NCT01223534.
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://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=13081
url https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=13081
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-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname:Fundació Sant Joan de Déu
instname_str Fundació Sant Joan de Déu
reponame_str r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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