Epidemiological Study on Invasive Bacterial Diseases

Epidemiological Study on Invasive Bacterial Diseases (IBD)

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Bacterial Diseases (IBD)
• Intervention / Treatment: Diagnostic test: assessment of pathogens in blood specimens

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Chiara Azzari, MD; Phone Number: 00390555662542; Email: chiara.azzari@meyer.it

Study Locations

• Italy
  • Adria, Italy
    • Not yet recruiting
    • Ospedale di Adria
  • Ancona, Italy
    • Not yet recruiting
    • Ospedali Riuniti Di Ancona
  • Andria, Italy
    • Not yet recruiting
    • Ospedale di Andria
  • Bari, Italy
    • Not yet recruiting
    • Ospedale Giovanni XXIII
  • Bologna, Italy
    • Not yet recruiting
    • Policlinico S.Orsola-Malpighi IRCCS
  • Brescia, Italy
    • Not yet recruiting
    • Fondazione poliambulanza Brescia
  • Brescia, Italy
    • Not yet recruiting
    • Ospedale Giovanni XXIII
  • Campobasso, Italy
    • Not yet recruiting
    • Ospedale di Campobasso
  • Camposampiero, Italy
    • Not yet recruiting
    • Ospedale Camposampiero
  • Esine, Italy
    • Not yet recruiting
    • Ospedale di Esine asst Valcamonica
  • Feltre, Italy
    • Not yet recruiting
    • Ospedale di Feltre (AULSS 1 Dolomiti)
  • Florence, Italy
    • Recruiting
    • Immunology Laboratory Meyer Children's Hospital IRCCS
    • Contact: Chiara Azzari, MD; Phone Number: 00390555662542
  • Forlì, Italy
    • Not yet recruiting
    • Ospedale Morgagni
  • Garbagnate, Italy
    • Not yet recruiting
    • AO Salvini di Garbagnate
  • Gorizia, Italy
    • Not yet recruiting
    • Azienda sanitaria universitaria Giuliano Isontina (ASU GI)
  • Macerata, Italy
    • Not yet recruiting
    • Ospedale di Macerata
  • Magenta, Italy
    • Not yet recruiting
    • Ospedale di Magenta
  • Messina, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Policlinico Universitario "G. Martino"
  • Milano, Italy
    • Not yet recruiting
    • IRCCS San Raffaele
  • Napoli, Italy
    • Not yet recruiting
    • AORN Santobono
  • Napoli, Italy
    • Not yet recruiting
    • AOU Federico II di Napoli
  • Novara, Italy
    • Not yet recruiting
    • Ospedale di Novara
  • Pavia, Italy
    • Not yet recruiting
    • Fondazione I.R.C.C.S. Policlinico San Matteo
  • Pescara, Italy
    • Not yet recruiting
    • Ospedale spirito santo di Pescara
  • Pordenone, Italy
    • Not yet recruiting
    • Azienda sanitaria Friuli occidentale
  • Rimini, Italy
    • Not yet recruiting
    • Ospedale Degli Infermi
  • Roma, Italy
    • Not yet recruiting
    • Ospedale Sandro Pertini
  • Roma, Italy
    • Not yet recruiting
    • Ospedale Pediatrico Bambin Gesù IRCCS
  • Salerno, Italy
    • Not yet recruiting
    • Ospedale San Leonardo di Salerno
  • Saronno, Italy
    • Not yet recruiting
    • Ospedale di Saronno
  • Sassari, Italy
    • Not yet recruiting
    • AOU Sassari
  • Scorrano, Italy
    • Not yet recruiting
    • Ospedale di Scorrano
  • Trapani, Italy
    • Not yet recruiting
    • ASP Trapani
  • Trieste, Italy
    • Not yet recruiting
    • IRCCS Materno Infantile Burlo Garofolo
  • Udine, Italy
    • Not yet recruiting
    • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
  • Verona, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
  • Vibo Valentia, Italy
    • Not yet recruiting
    • Ospedale civile di Vibo Valentia
  • Ì
    • Bologna, Ì, Italy
      • Not yet recruiting
      • Ospedale Maggiore Carlo Alberto Pizzardi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Other type of bacterial infections.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases; Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases, as defined in the Italian Superior Institute of Health (ISS) protocol.	Diagnostic test: assessment of pathogens in blood specimens; Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age.	Monitor the trend of Infective Bacterial Diseases cases Streptococcus pneumoniae (pneumococcus) in Italy, during pediatric age.	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.	Frequencies of Infective Bacterial Diseases cases from Neisseria meningitidis in Italy (meningococcus)	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.	Frequencies of Infective Bacterial Diseases cases from Haemophilus influenzae (hemophilus) in Italy	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.	Describe the distribution of circulating serogroups/serotypes	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	Estimate the proportion of these invasive infections that are preventable by vaccine	Through study completion, an average of 1 yeary
Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.	Assessing rate cases of vaccine failure	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): March 30, 2032

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: SEMBAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No