Epidemiological Study on Invasive Bacterial Diseases

Last updated: March 18, 2024
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bacterial Infections

Treatment

assessment of pathogens in blood specimens

Clinical Study ID

NCT06322290
SEMBAI
  • Ages 1-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Other type of bacterial infections.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: assessment of pathogens in blood specimens
Phase:
Study Start date:
December 09, 2021
Estimated Completion Date:
March 30, 2032

Study 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.

Connect with a study center

  • Ospedale Maggiore Carlo Alberto Pizzardi

    Bologna, Ì
    Italy

    Site Not Available

  • Ospedale di Adria

    Adria,
    Italy

    Site Not Available

  • Ospedali riuniti di Ancona

    Ancona,
    Italy

    Site Not Available

  • Ospedale di Andria

    Andria,
    Italy

    Site Not Available

  • Ospedale Giovanni XXIII

    Bari,
    Italy

    Site Not Available

  • Policlinico S.Orsola-Malpighi IRCCS

    Bologna,
    Italy

    Site Not Available

  • Fondazione poliambulanza Brescia

    Brescia,
    Italy

    Site Not Available

  • Ospedale Giovanni XXIII

    Brescia,
    Italy

    Site Not Available

  • Ospedale di Campobasso

    Campobasso,
    Italy

    Site Not Available

  • Ospedale Camposampiero

    Camposampiero,
    Italy

    Site Not Available

  • Ospedale di Esine asst Valcamonica

    Esine,
    Italy

    Site Not Available

  • Ospedale di Feltre (AULSS 1 Dolomiti)

    Feltre,
    Italy

    Site Not Available

  • Immunology Laboratory Meyer Children's Hospital IRCCS

    Florence,
    Italy

    Active - Recruiting

  • Ospedale Morgagni

    Forlì,
    Italy

    Site Not Available

  • AO Salvini di Garbagnate

    Garbagnate,
    Italy

    Site Not Available

  • Azienda sanitaria universitaria Giuliano Isontina (ASU GI)

    Gorizia,
    Italy

    Site Not Available

  • Ospedale di Macerata

    Macerata,
    Italy

    Site Not Available

  • Ospedale di Magenta

    Magenta,
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico Universitario "G. Martino"

    Messina,
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Milano,
    Italy

    Site Not Available

  • AORN Santobono

    Napoli,
    Italy

    Site Not Available

  • AOU Federico II di Napoli

    Napoli,
    Italy

    Site Not Available

  • Ospedale di Novara

    Novara,
    Italy

    Site Not Available

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • Ospedale spirito santo di Pescara

    Pescara,
    Italy

    Site Not Available

  • Azienda sanitaria Friuli occidentale

    Pordenone,
    Italy

    Site Not Available

  • Ospedale degli infermi

    Rimini,
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambin Gesù IRCCS

    Roma,
    Italy

    Site Not Available

  • Ospedale Sandro Pertini

    Roma,
    Italy

    Site Not Available

  • Ospedale San Leonardo di Salerno

    Salerno,
    Italy

    Site Not Available

  • Ospedale di Saronno

    Saronno,
    Italy

    Site Not Available

  • AOU Sassari

    Sassari,
    Italy

    Site Not Available

  • Ospedale di Scorrano

    Scorrano,
    Italy

    Site Not Available

  • ASP Trapani

    Trapani,
    Italy

    Site Not Available

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste,
    Italy

    Site Not Available

  • Azienda sanitaria universitaria Friuli Centrale (ASU FC)

    Udine,
    Italy

    Site Not Available

  • Azienda ospedaliera universitaria integrata Verona

    Verona,
    Italy

    Site Not Available

  • Ospedale civile di Vibo Valentia

    Vibo Valentia,
    Italy

    Site Not Available

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