QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing : A Noninferiority Clinical Trial
© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissionsoup.com..
Background: Screening strategies based on interferon-γ 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.
| Errataetall: |
CommentIn: Clin Infect Dis. 2018 Sep 28;67(8):1308. - PMID 29912296 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:66 |
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| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - 66(2018), 3 vom: 18. Jan., Seite 396-403 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Muñoz, Laura [VerfasserIn] |
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| Links: |
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| Themen: |
Equivalence Trial |
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| Anmerkungen: |
Date Completed 21.10.2019 Date Revised 22.10.2019 published: Print ClinicalTrials.gov: NCT01223534 CommentIn: Clin Infect Dis. 2018 Sep 28;67(8):1308. - PMID 29912296 Citation Status MEDLINE |
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| doi: |
10.1093/cid/cix745 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM276892038 |
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| 500 | |a Date Completed 21.10.2019 | ||
| 500 | |a Date Revised 22.10.2019 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01223534 | ||
| 500 | |a CommentIn: Clin Infect Dis. 2018 Sep 28;67(8):1308. - PMID 29912296 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissionsoup.com. | ||
| 520 | |a Background: Screening strategies based on interferon-γ release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 520 | |a Clinical Trials Registration: NCT01223534 | ||
| 650 | 4 | |a Equivalence Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a interferon-gamma release assays | |
| 650 | 4 | |a latent tuberculosis infection | |
| 650 | 4 | |a preventive therapy | |
| 650 | 4 | |a tuberculin skin test | |
| 650 | 7 | |a Reagent Kits, Diagnostic |2 NLM | |
| 700 | 1 | |a Santin, Miguel |e verfasserin |4 aut | |
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| 700 | 1 | |a Ramírez, Encarnación |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez-Escolano, Elvira |e verfasserin |4 aut | |
| 700 | 1 | |a López-Prieto, María Dolores |e verfasserin |4 aut | |
| 700 | 1 | |a Gutiérrez-Rodriguez, José |e verfasserin |4 aut | |
| 700 | 1 | |a Anibarro, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Calviño, Laura |e verfasserin |4 aut | |
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| 700 | 1 | |a Montilla, Pedro |e investigator |4 oth | |
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| 700 | 1 | |a Sandova, Santiago |e investigator |4 oth | |
| 700 | 1 | |a Prieto, María |e investigator |4 oth | |
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| 700 | 1 | |a Sande, Diana |e investigator |4 oth | |
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| 700 | 1 | |a Barrera, Felipe |e investigator |4 oth | |
| 700 | 1 | |a López-Prieto, María Dolores |e investigator |4 oth | |
| 700 | 1 | |a Gutiérrez-Rodríguez, José |e investigator |4 oth | |
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| 700 | 1 | |a Cifuentes, Carmen |e investigator |4 oth | |
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| 700 | 1 | |a Santin, Miguel |e investigator |4 oth | |
| 700 | 1 | |a González, Lucía |e investigator |4 oth | |
| 700 | 1 | |a Guerra, Maria R |e investigator |4 oth | |
| 700 | 1 | |a Dorca, Jordi |e investigator |4 oth | |
| 700 | 1 | |a Alcaide, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Moure, Raquel |e investigator |4 oth | |
| 700 | 1 | |a Ferrer, Anna |e investigator |4 oth | |
| 700 | 1 | |a Gasch, Oriol |e investigator |4 oth | |
| 700 | 1 | |a Granados, Ana |e investigator |4 oth | |
| 700 | 1 | |a Calzado, Sonia |e investigator |4 oth | |
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| 700 | 1 | |a Torres, Adoración |e investigator |4 oth | |
| 700 | 1 | |a Espasa, Mateu |e investigator |4 oth | |
| 700 | 1 | |a Cruel, Miquel |e investigator |4 oth | |
| 700 | 1 | |a Agüero, Ramón |e investigator |4 oth | |
| 700 | 1 | |a Ferrer, Diego |e investigator |4 oth | |
| 700 | 1 | |a Ruiz, Juan J |e investigator |4 oth | |
| 700 | 1 | |a Álvarez, Mercedes |e investigator |4 oth | |
| 700 | 1 | |a Cólera, Laura |e investigator |4 oth | |
| 700 | 1 | |a Agüero, Jesús |e investigator |4 oth | |
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| 700 | 1 | |a Gimenez, Teresa |e investigator |4 oth | |
| 700 | 1 | |a Ramírez-Lapausa, Marta |e investigator |4 oth | |
| 700 | 1 | |a Carrillo, Raquel |e investigator |4 oth | |
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| 700 | 1 | |a Royo, José I |e investigator |4 oth | |
| 700 | 1 | |a Bikuña, Edurne |e investigator |4 oth | |
| 700 | 1 | |a Urbieta, Lourdes |e investigator |4 oth | |
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| 700 | 1 | |a Muruaga, Jesús M |e investigator |4 oth | |
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| 700 | 1 | |a Vicedo, Salud |e investigator |4 oth | |
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| 700 | 1 | |a Gil, Gabriel |e investigator |4 oth | |
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