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NCT Number: NCT06322290

Epidemiological Study on Invasive Bacterial Diseases

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.

Recruiting

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Key information

Age range

1 day–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Ì, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other type of bacterial infections.

Treatment and study plan

assessment of pathogens in blood specimens

Diagnostic Test

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

Primary outcomes

  1. 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

    Monitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age.

  2. 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

    Frequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus)

  3. 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

    Frequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy

Secondary outcomes

  1. Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.

    Time frame: Through study completion, an average of 1 year

    Describe the distribution of circulating serogroups/serotypes

  2. 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

    Estimate the proportion of these invasive infections that are preventable by vaccine

  3. Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.

    Time frame: Through study completion, an average of 1 year

    Assessing rate cases of vaccine failure

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Azzari, MD

CONTACT

[email protected]

00390555662542

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Epidemiological Study on Invasive Bacterial Diseases (IBD)

Important dates

Study start
2021
Primary completion
2031
Study completion
2032
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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