Clinical trial NCT06322290: Epidemiological Study on Invasive Bacterial Diseases
Official title: Epidemiological Study on Invasive Bacterial Diseases (IBD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Bacterial Diseases (IBD)
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy

Brief summary: 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.

Detailed description: Pathogen identification by culture methods has been shown to be unsatisfactory, as antibiotic therapy carried out in patients before hospitalization prevents bacterial culture development and subsequent typing in many cases. In addition, technical problems due to sample collection, storage and transport reduce germ viability leading to false negatives in pathogen identification by culture methods. In contrast, molecular diagnosis allows germ identification on biological samples even in the absence of germ viability, thus enabling more accurate diagnosis.

Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiological trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.In 2006, the AOU Meyer Immunology Laboratory received a grant from the National Center for Disease Prevention and Control (NCDC) to develop a molecular diagnostic method for surveillance of invasive infections with Neisseria meningitidis (meningococcal,) Streptococcus pneumoniae (pneumococcus) and Haemophilus influenzae (hemophilus) that would allow identification of the germ on biological samples even in the absence of germ viability, with a view to improving surveillance, prevention and treatment strategies. The project involved performing molecular diagnostic tests on samples from patients referred to hospitals in the Tuscany Region and outside the region. 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.

Eligibility criteria: Inclusion Criteria:

* Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI

Exclusion Criteria:

* Other type of bacterial infections.

Primary outcomes:
measure: Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age.
timeFrame: Through study completion, an average of 1 year
measure: Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age.
timeFrame: Through study completion, an average of 1 year
measure: Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.
timeFrame: Through study completion, an average of 1 year
measure: Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy
timeFrame: Through study completion, an average of 1 yeary
measure: Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Adria
country: Italy
facility: Ospedale di Adria
city: Ancona
country: Italy
facility: Ospedali riuniti di Ancona
city: Andria
country: Italy
facility: Ospedale di Andria
city: Bari
country: Italy
facility: Ospedale Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi IRCCS
city: Brescia
country: Italy
facility: Fondazione poliambulanza Brescia
city: Brescia
country: Italy
facility: Ospedale Giovanni XXIII
city: Campobasso
country: Italy
facility: Ospedale di Campobasso
city: Camposampiero
country: Italy
facility: Ospedale Camposampiero
city: Esine
country: Italy
facility: Ospedale di Esine asst Valcamonica
city: Feltre
country: Italy
facility: Ospedale di Feltre (AULSS 1 Dolomiti)
city: Florence
country: Italy
facility: Immunology Laboratory Meyer Children's Hospital IRCCS
city: Forlì
country: Italy
facility: Ospedale Morgagni
city: Garbagnate
country: Italy
facility: AO Salvini di Garbagnate
city: Gorizia
country: Italy
facility: Azienda sanitaria universitaria Giuliano Isontina (ASU GI)
city: Macerata
country: Italy
facility: Ospedale di Macerata
city: Magenta
country: Italy
facility: Ospedale di Magenta
city: Messina
country: Italy
facility: Azienda Ospedaliera Policlinico Universitario "G. Martino"
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Napoli
country: Italy
facility: AORN Santobono
city: Napoli
country: Italy
facility: AOU Federico II di Napoli
city: Novara
country: Italy
facility: Ospedale di Novara
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Pescara
country: Italy
facility: Ospedale spirito santo di Pescara
city: Pordenone
country: Italy
facility: Azienda sanitaria Friuli occidentale
city: Rimini
country: Italy
facility: Ospedale degli infermi
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambin Gesù IRCCS
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Salerno
country: Italy
facility: Ospedale San Leonardo di Salerno
city: Saronno
country: Italy
facility: Ospedale di Saronno
city: Sassari
country: Italy
facility: AOU Sassari
city: Scorrano
country: Italy
facility: Ospedale di Scorrano
city: Trapani
country: Italy
facility: ASP Trapani
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo
city: Udine
country: Italy
facility: Azienda sanitaria universitaria Friuli Centrale (ASU FC)
city: Verona
country: Italy
facility: Azienda ospedaliera universitaria integrata Verona
city: Vibo Valentia
country: Italy
facility: Ospedale civile di Vibo Valentia
city: Bologna
country: Italy
facility: Ospedale Maggiore Carlo Alberto Pizzardi
state: Ì
Study officials:
References: