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Multicenter Study Clinical Trial
Tuberculosis infection in children visiting friends and relatives in countries with high incidence of tuberculosis: A study protocol.
- Antoni Soriano-Arandes, Joan A Caylà, Alessandra Queiroga Gonçalves, Àngels Orcau, Antoni Noguera-Julian, Emma Padilla, Elisabet Solà-Segura, Neus Rius Gordillo, María Espiau, Mónica G García-Lerín, Maria Àngels Rifà-Pujol, Jordi Gómez I PratEquip de Salut Pública i Comunitària de la Unitat de Salut Internacional Drassanes-Hospital Universitari Vall d'Hebron, Servei de Medicina Preventiva de Vall d'Hebron, Barcelona., Esperança Macia-Rieradevall, Andrea Martin-Nalda, Maria Eril-Rius, José Santos Santiago, Lídia Busquets-Poblet, Raisa Morales Martínez, and Tomàs Maria Pérez-Porcuna.
- Unitat de Patologia Infecciosa i Immunodeficiències Pediàtriques, Vall d'Hebron Institut de Recerca (VHIR), Hospital Universitari Vall d'Hebron.
- Medicine (Baltimore). 2020 Sep 4; 99 (36): e22015.
IntroductionTuberculosis (TB) is a global infectious disease. In low-incidence countries, paediatric TB affects mostly immigrant children and children of immigrants. We hypothesize that these children are at risk of exposure to Mycobacterium tuberculosis when they travel to the country of origin of their parents to visit friends and relatives (VFR). In this study, we aim to estimate the incidence rate and risk factors associated to latent tuberculosis infection (LTBI) and TB in VFR children.Methods And AnalysisA prospective study will be carried out in collaboration with 21 primary health care centres (PCC) and 5 hospitals in Catalonia, Spain. The study participants are children under 15 years of age, either immigrant themselves or born to immigrant parents, who travel to countries with high incidence of TB (≥ 40 cases/100,000 inhabitants). A sample size of 492 children was calculated. Participants will be recruited before traveling, either during a visit to a travel clinic or to their PCC, where a questionnaire including sociodemographic, epidemiological and clinical data will be completed, and a tuberculin skin test (TST) will be performed and read after 48 to 72 hours; patients with a positive TST at baseline will be excluded. A visit will be scheduled eight to twelve-weeks after their return to perform a TST and a QuantiFERON-TB Gold Plus test. The incidence rate of LTBI will be estimated per individual/month and person/year per country visited, and also by age-group.Ethics And DisseminationThe study protocol was approved by the Clinical Research Ethics Committee of the Hospital Universitari Mútua Terrassa (code 02/16) and the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P16/094). Articles will be published in indexed scientific journals.Trial RegistrationClinical-Trials.gov: NCT04236765.
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