protocolSection identificationModule nctId: NCT06289660, orgStudyIdInfo id: PED-TB22, briefTitle: Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-22, primaryCompletionDateStruct date: 2033-01-02, completionDateStruct date: 2033-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide., conditionsModule conditions: Tuberculosis Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Epidemiology of Tuberculosis, eligibilityModule sex: ALL, minimumAge: 1 Week, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, zip: 50139, country: Italy, contacts name: Luisa Galli, role: CONTACT, email: luisa.galli@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Pediatrico Giovanni XXIII, status: RECRUITING, city: Bari, country: Italy, contacts name: Desiree Caselli, role: CONTACT, email: desiree.caselli@policlinico.ba.it, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale di Belluno, status: RECRUITING, city: Belluno, country: Italy, contacts name: Giangiacomo Nicolini, role: CONTACT, email: gnicolini@gmail.com, geoPoint lat: 46.14262, lon: 12.2156, locations facility: Università di Bologna, status: RECRUITING, city: Bologna, country: Italy, contacts name: Marcello Lanari, role: CONTACT, email: marcello.lanari@unibo.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: IRCCS Istituto Giannina Gaslini, status: RECRUITING, city: Genova, country: Italy, contacts name: Elio Castagnola, role: CONTACT, email: eliocastagnola@gaslini.org, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico, status: RECRUITING, city: Milano, country: Italy, contacts name: Samantha Bosis, MD, role: CONTACT, email: samantha.bosis@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Luigi Sacco, status: RECRUITING, city: Milano, country: Italy, contacts name: Vania Giacomet, role: CONTACT, email: vania.giacomet@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Barbara Maria Bergamini, role: CONTACT, email: bergamini.barbaramaria@unimo.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Università Federico II, status: RECRUITING, city: Napoli, country: Italy, contacts name: Andrea Lo Vecchio, role: CONTACT, email: andrea.lovecchio@unina.it, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale dei Bambini "G.Di Cristina", status: RECRUITING, city: Palermo, country: Italy, contacts name: Claudia Colomba, MD, role: CONTACT, email: claudia.colomba@unipa.it, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale di Parma, status: RECRUITING, city: Parma, country: Italy, contacts name: Susanna Maria Roberta Esposito, role: CONTACT, email: susannamariaroberta.esposito@unipr.it, geoPoint lat: 44.79935, lon: 10.32618, locations facility: IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: Gian Luigi Marseglia, role: CONTACT, email: gl.marseglia@smatteo.pv.it, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Azienda Ospedaliero Universitaria Pisana, status: RECRUITING, city: Pisa, country: Italy, contacts name: Diego Peroni, role: CONTACT, email: diego.peroni@unipi.it, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Azienda USL Toscana Centro, status: RECRUITING, city: Prato, country: Italy, contacts name: Per Luigi Vasarri, role: CONTACT, email: pvasarri@usl4.toscana.it, geoPoint lat: 43.8805, lon: 11.09699, locations facility: IRCCS Ospedale Pediatrico Bambin Gesù, status: RECRUITING, city: Roma, country: Italy, contacts name: Laura Lancella, role: CONTACT, email: laura.lancella@opbg.net, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, country: Italy, contacts name: Danilo Buonsenso, MD, role: CONTACT, email: danilo.buonsenso@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Regina Margherita, status: RECRUITING, city: Torino, country: Italy, contacts name: Silvia Garazzino, role: CONTACT, email: silvia.garazzino@unito.it, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False