Epidemiological Study on Invasive Bacterial Diseases
- Conditions
- Invasive Bacterial Diseases (IBD)
- Interventions
- Diagnostic Test: assessment of pathogens in blood specimens
- Registration Number
- NCT06322290
- Lead Sponsor
- Meyer Children's Hospital IRCCS
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI
- Other type of bacterial infections.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases assessment of pathogens in blood specimens Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases, as defined in the Italian Superior Institute of Health (ISS) protocol.
- Primary Outcome Measures
Name Time Method Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age. Through study completion, an average of 1 year Frequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus)
Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. Through study completion, an average of 1 year Monitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age.
Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age. Through study completion, an average of 1 year Frequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy
- Secondary Outcome Measures
Name Time Method Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy Through study completion, an average of 1 yeary Estimate the proportion of these invasive infections that are preventable by vaccine
Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. Through study completion, an average of 1 year Describe the distribution of circulating serogroups/serotypes
Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. Through study completion, an average of 1 year Assessing rate cases of vaccine failure
Trial Locations
- Locations (37)
Ospedali riuniti di Ancona
🇮🇹Ancona, Italy
Ospedale di Andria
🇮🇹Andria, Italy
Ospedale Giovanni XXIII
🇮🇹Brescia, Italy
Ospedale Camposampiero
🇮🇹Camposampiero, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Ospedale di Campobasso
🇮🇹Campobasso, Italy
Immunology Laboratory Meyer Children's Hospital IRCCS
🇮🇹Florence, Italy
Ospedale di Magenta
🇮🇹Magenta, Italy
ASP Trapani
🇮🇹Trapani, Italy
Policlinico S.Orsola-Malpighi IRCCS
🇮🇹Bologna, Italy
Fondazione poliambulanza Brescia
🇮🇹Brescia, Italy
AO Salvini di Garbagnate
🇮🇹Garbagnate, Italy
Ospedale di Feltre (AULSS 1 Dolomiti)
🇮🇹Feltre, Italy
Azienda Ospedaliera Policlinico Universitario "G. Martino"
🇮🇹Messina, Italy
AORN Santobono
🇮🇹Napoli, Italy
Ospedale di Novara
🇮🇹Novara, Italy
Ospedale San Leonardo di Salerno
🇮🇹Salerno, Italy
Ospedale di Scorrano
🇮🇹Scorrano, Italy
Ospedale civile di Vibo Valentia
🇮🇹Vibo Valentia, Italy
Ospedale Sandro Pertini
🇮🇹Roma, Italy
Ospedale di Adria
🇮🇹Adria, Italy
Ospedale di Esine asst Valcamonica
🇮🇹Esine, Italy
Ospedale Morgagni
🇮🇹Forlì, Italy
Ospedale di Macerata
🇮🇹Macerata, Italy
AOU Federico II di Napoli
🇮🇹Napoli, Italy
Ospedale Pediatrico Bambin Gesù IRCCS
🇮🇹Roma, Italy
Azienda sanitaria universitaria Giuliano Isontina (ASU GI)
🇮🇹Gorizia, Italy
Azienda sanitaria Friuli occidentale
🇮🇹Pordenone, Italy
Ospedale di Saronno
🇮🇹Saronno, Italy
Ospedale spirito santo di Pescara
🇮🇹Pescara, Italy
Ospedale degli infermi
🇮🇹Rimini, Italy
IRCCS Materno Infantile Burlo Garofolo
🇮🇹Trieste, Italy
AOU Sassari
🇮🇹Sassari, Italy
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
🇮🇹Udine, Italy
Ospedale Maggiore Carlo Alberto Pizzardi
🇮🇹Bologna, Ì, Italy
Azienda ospedaliera universitaria integrata Verona
🇮🇹Verona, Italy