RT Journal Article
T1 QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial.
A1 Muñoz, Laura
A1 Santin, Miguel
A1 Alcaide, Fernando
A1 Ruíz-Serrano, Maria Jesús
A1 Gijón, Paloma
A1 Bermúdez, Elena
A1 Domínguez-Castellano, Angel
A1 Navarro, María Dolores
A1 Ramírez, Encarnación
A1 Pérez-Escolano, Elvira
A1 López-Prieto, María Dolores
A1 Gutiérrez-Rodriguez, José
A1 Anibarro, Luis
A1 Calviño, Laura
A1 Trigo, Matilde
A1 Cifuentes, Carmen
A1 García-Gasalla, Mercedes
A1 Payeras, Antoni
A1 Gasch, Oriol
A1 Espasa, Mateu
A1 Agüero, Ramon
A1 Ferrer, Diego
A1 Casas, Xavier
A1 González-Cuevas, Araceli
A1 García-Zamalloa, Alberto
A1 Bikuña, Edurne
A1 Lecuona, María
A1 Galindo, Rosa
A1 Ramírez-Lapausa, Marta
A1 Carrillo, Raquel
A1 OPTIMIST Study Team, 
K1 interferon-gamma release assays
K1 latent tuberculosis infection
K1 preventive therapy
K1 tuberculin skin test
AB Screening strategies based on interferon-γ release assays in tuberculosis contact tracing may reduce the need for preventive therapy without increasing subsequent active disease. 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. 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%). 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. NCT01223534.
YR 2018
FD 2018
LK http://hdl.handle.net/10668/11668
UL http://hdl.handle.net/10668/11668
LA en
DS RISalud
RD Apr 11, 2025