Epidemiological Study on Invasive Bacterial Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: assessment of pathogens in blood specimens.
- Who it may be relevant to
- Registry conditions: Invasive Bacterial Diseases (IBD). Basic parameters: 1 Day — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Epidemiological Study on Invasive Bacterial Diseases (IBD)
Overview
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.
Interventions
- Diagnostic test assessment of pathogens in blood specimens
Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae
Primary outcome measures
- Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. [Time frame: 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. [Time frame: 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. [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
- Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. [Time frame: 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 [Time frame: Through study completion, an average of 1 yeary]
- Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI
Exclusion criteria
- Other type of bacterial infections.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 38 centers
- Ospedale di Adria — Adria
- Ospedali riuniti di Ancona — Ancona
- Ospedale di Andria — Andria
- Ospedale Giovanni XXIII — Bari
- Policlinico S.Orsola-Malpighi IRCCS — Bologna
- Fondazione poliambulanza Brescia — Brescia
- Ospedale Giovanni XXIII — Brescia
- Ospedale di Campobasso — Campobasso
- … and 30 more centers
Identifiers
NCT: NCT06322290 · SEMBAI