Epidemiological Study on Invasive Bacterial Diseases

Recruiting

• Conditions: Invasive Bacterial Diseases (IBD)

• 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.

Study Timeline

• Study Start: 2021-12-09
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2031-12-30
• Study Completion: 2032-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Other type of bacterial infections.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

Ospedale di Adria; 🇮🇹 Adria, Italy

Ospedali riuniti di Ancona; 🇮🇹 Ancona, Italy

Ospedale di Andria; 🇮🇹 Andria, Italy

Ospedale Giovanni XXIII; 🇮🇹 Brescia, Italy

Policlinico S.Orsola-Malpighi IRCCS; 🇮🇹 Bologna, Italy

Fondazione poliambulanza Brescia; 🇮🇹 Brescia, Italy

Ospedale di Campobasso; 🇮🇹 Campobasso, Italy

Ospedale Camposampiero; 🇮🇹 Camposampiero, Italy

Ospedale di Esine asst Valcamonica; 🇮🇹 Esine, Italy

Ospedale di Feltre (AULSS 1 Dolomiti); 🇮🇹 Feltre, Italy

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