Epidemiological Study on Invasive Bacterial Diseases

NCT06322290 | Recruiting

• 1 other identifier: SEMBAI
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 38

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.

Conditions

Invasive Bacterial Diseases (IBD)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  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

  Through study completion, an average of 1 yeary

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

  Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

assessment of pathogens in blood specimens DIAGNOSTIC_TEST

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

pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases

Eligibility Criteria

• Age: 1 Day - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Other type of bacterial infections.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (38)

Ospedale di Adria

Adria, Italy

NOT YET RECRUITING

Ospedali riuniti di Ancona

Ancona, Italy

NOT YET RECRUITING

Ospedale di Andria

Andria, Italy

NOT YET RECRUITING

Ospedale Giovanni XXIII

Bari, Italy

NOT YET RECRUITING

Policlinico S.Orsola-Malpighi IRCCS

Bologna, Italy

NOT YET RECRUITING

Fondazione poliambulanza Brescia

Brescia, Italy

NOT YET RECRUITING

Ospedale Giovanni XXIII

Brescia, Italy

NOT YET RECRUITING

Ospedale di Campobasso

Campobasso, Italy

NOT YET RECRUITING

Ospedale Camposampiero

Camposampiero, Italy

NOT YET RECRUITING

Ospedale di Esine asst Valcamonica

Esine, Italy

NOT YET RECRUITING

Ospedale di Feltre (AULSS 1 Dolomiti)

Feltre, Italy

NOT YET RECRUITING

Immunology Laboratory Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Ospedale Morgagni

Forlì, Italy

NOT YET RECRUITING

AO Salvini di Garbagnate

Garbagnate, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Giuliano Isontina (ASU GI)

Gorizia, Italy

NOT YET RECRUITING

Ospedale di Macerata

Macerata, Italy

NOT YET RECRUITING

Ospedale di Magenta

Magenta, Italy

NOT YET RECRUITING

Azienda Ospedaliera Policlinico Universitario "G. Martino"

Messina, Italy

NOT YET RECRUITING

IRCCS San Raffaele

Milan, Italy

NOT YET RECRUITING

AORN Santobono

Napoli, Italy

NOT YET RECRUITING

AOU Federico II di Napoli

Napoli, Italy

NOT YET RECRUITING

Ospedale di Novara

Novara, Italy

NOT YET RECRUITING

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

Pavia, Italy

NOT YET RECRUITING

Ospedale spirito santo di Pescara

Pescara, Italy

NOT YET RECRUITING

Azienda sanitaria Friuli occidentale

Pordenone, Italy

NOT YET RECRUITING

Ospedale degli infermi

Rimini, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambin Gesù IRCCS

Roma, Italy

NOT YET RECRUITING

Ospedale Sandro Pertini

Roma, Italy

NOT YET RECRUITING

Ospedale San Leonardo di Salerno

Salerno, Italy

NOT YET RECRUITING

Ospedale di Saronno

Saronno, Italy

NOT YET RECRUITING

AOU Sassari

Sassari, Italy

NOT YET RECRUITING

Ospedale di Scorrano

Scorrano, Italy

NOT YET RECRUITING

ASP Trapani

Trapani, Italy

NOT YET RECRUITING

IRCCS Materno Infantile Burlo Garofolo

Trieste, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Friuli Centrale (ASU FC)

Udine, Italy

NOT YET RECRUITING

Azienda ospedaliera universitaria integrata Verona

Verona, Italy

NOT YET RECRUITING

Ospedale civile di Vibo Valentia

Vibo Valentia, Italy

NOT YET RECRUITING

Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, Ì, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for bacterial identification

Central Study Contacts

Chiara Azzari, MD

CONTACT

00390555662542; chiara.azzari@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 21, 2024
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): March 30, 2032
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (38)