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Epidemiological Study on Invasive Bacterial Diseases

Epidemiological Study on Invasive Bacterial Diseases (IBD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06322290
Enrollment
5000
Registered
2024-03-21
Start date
2021-12-09
Completion date
2032-03-30
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Bacterial Diseases (IBD)

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.

Interventions

DIAGNOSTIC_TESTassessment of pathogens in blood specimens

Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Other type of bacterial infections.

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age.Through study completion, an average of 1 yearMonitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age.
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 yearFrequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus)
Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age.Through study completion, an average of 1 yearFrequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy

Secondary

MeasureTime frameDescription
Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.Through study completion, an average of 1 yearDescribe the distribution of circulating serogroups/serotypes
Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in ItalyThrough study completion, an average of 1 yearyEstimate the proportion of these invasive infections that are preventable by vaccine
Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.Through study completion, an average of 1 yearAssessing rate cases of vaccine failure

Countries

Italy

Contacts

Primary ContactChiara Azzari, MD
chiara.azzari@meyer.it00390555662542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026