QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial.
Por:
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, Gonzalez-Cuevas MA, García-Zamalloa A, Bikuña E, Lecuona M, Galindo R, Ramírez-Lapausa M and Carrillo R
Publicada:
18 ene 2018
Ahead of Print:
18 ago 2017
Resumen:
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.
Filiaciones:
Muñoz L:
Infectious Diseases Department
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat (Barcelona), Spain
Santin M:
Infectious Diseases Department
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat (Barcelona), Spain
Alcaide F:
Microbiology Department
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat (Barcelona), Spain
Ruíz-Serrano MJ:
Microbiology and Infectious Diseases Department
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Gijón P:
Microbiology and Infectious Diseases Department
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Bermúdez E:
Microbiology and Infectious Diseases Department
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Domínguez-Castellano A:
Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine
Hospital Virgen Macarena, Sevilla, Spain
Navarro MD:
Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine
Hospital Virgen Macarena, Sevilla, Spain
Ramírez E:
Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine
Hospital Virgen Macarena, Sevilla, Spain
Pérez-Escolano E:
Clinical Unit of Infectious Diseases and Microbiology
Hospital Jerez, Jerez de la Frontera (Cádiz), Spain
López-Prieto MD:
Clinical Unit of Infectious Diseases and Microbiology
Hospital Jerez, Jerez de la Frontera (Cádiz), Spain
Gutiérrez-Rodriguez J:
Preventive Medicine
Hospital Puerta del Mar, Cádiz, Spain
Anibarro L:
Infectious Diseases Unit
Complexo Hospitalario de Pontevedra, Pontevedra, Spain
Calviño L:
Infectious Diseases Unit
Complexo Hospitalario de Pontevedra, Pontevedra, Spain
Trigo M:
Microbiology Department
Complexo Hospitalario de Pontevedra, Pontevedra, Spain
Cifuentes C:
Internal Medicine Department
Hospital Son Llàtzer, Palma de Mallorca, Spain
García-Gasalla M:
Internal Medicine Department
Hospital Son Llàtzer, Palma de Mallorca, Spain
Payeras A:
Internal Medicine Department
Hospital Son Llàtzer, Palma de Mallorca, Spain
Gasch O:
Infectious Diseases Department
Corporació Sanitària Parc Taulí, Sabadell (Barcelona), Spain
Espasa M:
Microbiology Department
Corporació Sanitària Parc Taulí, Sabadell (Barcelona), Spain
Agüero R:
Respiratory Medicine
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Ferrer D:
Respiratory Medicine
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Casas X:
Respiratory Medicine Department
Parc Sanitari Sant Joan de Déu, Sant Boi (Barcelona), Spain
Gonzalez-Cuevas MA:
Microbiology Department
Parc Sanitari Sant Joan de Déu, Sant Boi (Barcelona), Spain
García-Zamalloa A:
Internal Medicine Department
Hospital de Mendaro, Mendaro (Gipuzkoa), Spain
Bikuña E:
Internal Medicine Department
Hospital de Mendaro, Mendaro (Gipuzkoa), Spain
Lecuona M:
Microbiology Department
Hospital Universitario de Canarias, La Laguna (Tenerife), Spain
Galindo R:
Respiratory Medicine
Hospital Universitario de Canarias, La Laguna (Tenerife), Spain
Ramírez-Lapausa M:
Internal Medicine Department
Hospital de Cantoblanco, Madrid, Spain
Carrillo R:
Internal Medicine Department
Hospital de Cantoblanco, Madrid, Spain
Open Access
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