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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases | Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases, as defined in the Italian Superior Institute of Health (ISS) protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of pathogens in blood specimens | Diagnostic Test | Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. | Monitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age. | Through study completion, an average of 1 year |
| Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age. | Frequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus) | Through study completion, an average of 1 year |
| Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age. | Frequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. | Describe the distribution of circulating serogroups/serotypes | Through study completion, an average of 1 year |
| Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Azzari, MD | Contact | 00390555662542 | chiara.azzari@meyer.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Adria | Not yet recruiting | Adria | Italy | |||
| Ospedali riuniti di Ancona |
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Blood samples for bacterial identification
Estimate the proportion of these invasive infections that are preventable by vaccine |
| Through study completion, an average of 1 yeary |
| Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. | Assessing rate cases of vaccine failure | Through study completion, an average of 1 year |
| Not yet recruiting |
| Ancona |
| Italy |
| Ospedale di Andria | Not yet recruiting | Andria | Italy |
| Ospedale Giovanni XXIII | Not yet recruiting | Bari | Italy |
| Policlinico S.Orsola-Malpighi IRCCS | Not yet recruiting | Bologna | Italy |
| Fondazione poliambulanza Brescia | Not yet recruiting | Brescia | Italy |
| Ospedale Giovanni XXIII | Not yet recruiting | Brescia | Italy |
| Ospedale di Campobasso | Not yet recruiting | Campobasso | Italy |
| Ospedale Camposampiero | Not yet recruiting | Camposampiero | Italy |
| Ospedale di Esine asst Valcamonica | Not yet recruiting | Esine | Italy |
| Ospedale di Feltre (AULSS 1 Dolomiti) | Not yet recruiting | Feltre | Italy |
| Immunology Laboratory Meyer Children's Hospital IRCCS | Recruiting | Florence | Italy |
|
| Ospedale Morgagni | Not yet recruiting | Forlì | Italy |
| AO Salvini di Garbagnate | Not yet recruiting | Garbagnate | Italy |
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) | Not yet recruiting | Gorizia | Italy |
| Ospedale di Magenta | Not yet recruiting | Magenta | Italy |
| Azienda Ospedaliera Policlinico Universitario "G. Martino" | Not yet recruiting | Messina | Italy |
| IRCCS San Raffaele | Not yet recruiting | Milan | Italy |
| AORN Santobono | Not yet recruiting | Naples | Italy |
| AOU Federico II di Napoli | Not yet recruiting | Naples | Italy |
| Ospedale di Novara | Not yet recruiting | Novara | Italy |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Not yet recruiting | Pavia | Italy |
| Ospedale spirito santo di Pescara | Not yet recruiting | Pescara | Italy |
| Azienda sanitaria Friuli occidentale | Not yet recruiting | Pordenone | Italy |
| Ospedale di Macerata | Not yet recruiting | Province of Macerata | Italy |
| Ospedale degli infermi | Not yet recruiting | Rimini | Italy |
| Ospedale Pediatrico Bambin Gesù IRCCS | Not yet recruiting | Roma | Italy |
| Ospedale Sandro Pertini | Not yet recruiting | Roma | Italy |
| Ospedale San Leonardo di Salerno | Not yet recruiting | Salerno | Italy |
| Ospedale di Saronno | Not yet recruiting | Saronno | Italy |
| AOU Sassari | Not yet recruiting | Sassari | Italy |
| Ospedale di Scorrano | Not yet recruiting | Scorrano | Italy |
| ASP Trapani | Not yet recruiting | Trapani | Italy |
| IRCCS Materno Infantile Burlo Garofolo | Not yet recruiting | Trieste | Italy |
| Azienda sanitaria universitaria Friuli Centrale (ASU FC) | Not yet recruiting | Udine | Italy |
| Azienda ospedaliera universitaria integrata Verona | Not yet recruiting | Verona | Italy |
| Ospedale civile di Vibo Valentia | Not yet recruiting | Vibo Valentia | Italy |
| Ospedale Maggiore Carlo Alberto Pizzardi | Not yet recruiting | Bologna | Ì | Italy |