• Clin. Infect. Dis. · Jan 2018

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

    • Laura Muñoz, Miguel Santin, Fernando Alcaide, Maria Jesús Ruíz-Serrano, Paloma Gijón, Elena Bermúdez, Angel Domínguez-Castellano, María Dolores Navarro, Encarnación Ramírez, Elvira Pérez-Escolano, María Dolores López-Prieto, José Gutiérrez-Rodriguez, Luis Anibarro, Laura Calviño, Matilde Trigo, Carmen Cifuentes, Mercedes García-Gasalla, Antoni Payeras, Oriol Gasch, Mateu Espasa, Ramon Agüero, Diego Ferrer, Xavier Casas, Araceli González-Cuevas, Alberto García-Zamalloa, Edurne Bikuña, María Lecuona, Rosa Galindo, Marta Ramírez-Lapausa, Raquel Carrillo, and OPTIMIST Study Team.
    • Department of Infectious Diseases, Hospital Universitari de Bellvitge-IDIBELL, Barcelona.
    • Clin. Infect. Dis. 2018 Jan 18; 66 (3): 396-403.

    BackgroundScreening strategies based on interferon-γ release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease.MethodsWe 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.ResultsA 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%).ConclusionsIn 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 RegistrationNCT01223534.© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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