protocolSection identificationModule nctId: NCT06322290, orgStudyIdInfo id: SEMBAI, briefTitle: Epidemiological Study on Invasive Bacterial Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-09, primaryCompletionDateStruct date: 2031-12-30, completionDateStruct date: 2032-03-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies., conditionsModule conditions: Invasive Bacterial Diseases (IBD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: assessment of pathogens in blood specimens, outcomesModule primaryOutcomes measure: Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age., primaryOutcomes measure: Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age., primaryOutcomes measure: Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age., secondaryOutcomes measure: Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae., secondaryOutcomes measure: Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy, secondaryOutcomes measure: Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale di Adria, status: NOT_YET_RECRUITING, city: Adria, country: Italy, geoPoint lat: 45.05445, lon: 12.05599, locations facility: Ospedali riuniti di Ancona, status: NOT_YET_RECRUITING, city: Ancona, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale di Andria, status: NOT_YET_RECRUITING, city: Andria, country: Italy, geoPoint lat: 41.23117, lon: 16.29797, locations facility: Ospedale Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bari, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Policlinico S.Orsola-Malpighi IRCCS, status: NOT_YET_RECRUITING, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Fondazione poliambulanza Brescia, status: NOT_YET_RECRUITING, city: Brescia, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale Giovanni XXIII, status: NOT_YET_RECRUITING, city: Brescia, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale di Campobasso, status: NOT_YET_RECRUITING, city: Campobasso, country: Italy, geoPoint lat: 41.55947, lon: 14.66737, locations facility: Ospedale Camposampiero, status: NOT_YET_RECRUITING, city: Camposampiero, country: Italy, geoPoint lat: 45.56368, lon: 11.93534, locations facility: Ospedale di Esine asst Valcamonica, status: NOT_YET_RECRUITING, city: Esine, country: Italy, geoPoint lat: 45.92515, lon: 10.25102, locations facility: Ospedale di Feltre (AULSS 1 Dolomiti), status: NOT_YET_RECRUITING, city: Feltre, country: Italy, geoPoint lat: 46.02085, lon: 11.90031, locations facility: Immunology Laboratory Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Chiara Azzari, MD, role: CONTACT, phone: 00390555662542, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Morgagni, status: NOT_YET_RECRUITING, city: Forlì, country: Italy, geoPoint lat: 44.22177, lon: 12.04144, locations facility: AO Salvini di Garbagnate, status: NOT_YET_RECRUITING, city: Garbagnate, country: Italy, geoPoint lat: 45.77027, lon: 9.29848, locations facility: Azienda sanitaria universitaria Giuliano Isontina (ASU GI), status: NOT_YET_RECRUITING, city: Gorizia, country: Italy, geoPoint lat: 45.94088, lon: 13.62167, locations facility: Ospedale di Macerata, status: NOT_YET_RECRUITING, city: Macerata, country: Italy, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Ospedale di Magenta, status: NOT_YET_RECRUITING, city: Magenta, country: Italy, geoPoint lat: 45.46456, lon: 8.88453, locations facility: Azienda Ospedaliera Policlinico Universitario "G. Martino", status: NOT_YET_RECRUITING, city: Messina, country: Italy, geoPoint lat: 38.19394, lon: 15.55256, locations facility: IRCCS San Raffaele, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: AORN Santobono, status: NOT_YET_RECRUITING, city: Napoli, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: AOU Federico II di Napoli, status: NOT_YET_RECRUITING, city: Napoli, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale di Novara, status: NOT_YET_RECRUITING, city: Novara, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione I.R.C.C.S. Policlinico San Matteo, status: NOT_YET_RECRUITING, city: Pavia, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale spirito santo di Pescara, status: NOT_YET_RECRUITING, city: Pescara, country: Italy, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Azienda sanitaria Friuli occidentale, status: NOT_YET_RECRUITING, city: Pordenone, country: Italy, geoPoint lat: 45.95689, lon: 12.66051, locations facility: Ospedale degli infermi, status: NOT_YET_RECRUITING, city: Rimini, country: Italy, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Ospedale Pediatrico Bambin Gesù IRCCS, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Leonardo di Salerno, status: NOT_YET_RECRUITING, city: Salerno, country: Italy, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Ospedale di Saronno, status: NOT_YET_RECRUITING, city: Saronno, country: Italy, geoPoint lat: 45.62513, lon: 9.03517, locations facility: AOU Sassari, status: NOT_YET_RECRUITING, city: Sassari, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Ospedale di Scorrano, status: NOT_YET_RECRUITING, city: Scorrano, country: Italy, geoPoint lat: 40.09018, lon: 18.29993, locations facility: ASP Trapani, status: NOT_YET_RECRUITING, city: Trapani, country: Italy, geoPoint lat: 38.0176, lon: 12.53617, locations facility: IRCCS Materno Infantile Burlo Garofolo, status: NOT_YET_RECRUITING, city: Trieste, country: Italy, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Azienda sanitaria universitaria Friuli Centrale (ASU FC), status: NOT_YET_RECRUITING, city: Udine, country: Italy, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Azienda ospedaliera universitaria integrata Verona, status: NOT_YET_RECRUITING, city: Verona, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Ospedale civile di Vibo Valentia, status: NOT_YET_RECRUITING, city: Vibo Valentia, country: Italy, geoPoint lat: 38.67618, lon: 16.10094, locations facility: Ospedale Maggiore Carlo Alberto Pizzardi, status: NOT_YET_RECRUITING, city: Bologna, state: Ì, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False