Epidemiological Study on Invasive Bacterial Diseases
ConditionInvasive Bacterial Diseases (IBD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-70
SponsorMeyer Children's Hospital IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI
Disqualifiers
Other type of bacterial infections.
Trial population
Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
assessment of pathogens in blood specimens
Diagnostic testMolecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year2
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)
Time frame
Through study completion, an average of 1 year3
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
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.
Describe the distribution of circulating serogroups/serotypes
Time frame
Through study completion, an average of 1 year2
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
Time frame
Through study completion, an average of 1 yeary3
Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.
Assessing rate cases of vaccine failure
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov