Invasive Bacterial Diseases (IBD)NCT06322290
Epidemiological Study on Invasive Bacterial Diseases
An observational study of Invasive Bacterial Diseases (IBD), run by Meyer Children's Hospital IRCCS at 38 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 70 years
- Conditions the study is for
- Invasive Bacterial Diseases (IBD)
- What is being tested?
- assessment of pathogens in blood specimens
- How many people
- 5,000 participants
- Where
- 38 sitesItaly
- Study dates
- 9 Dec 2021to 30 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy
Who may be able to join
- Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI
Who cannot join
- Other type of bacterial infections.
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
Italy38 sites, 38 recruiting
- Not yet recruiting
Ospedale di Adria
Adria
- Not yet recruiting
Ospedali riuniti di Ancona
Ancona
- Not yet recruiting
Ospedale di Andria
Andria
- Not yet recruiting
Ospedale Giovanni XXIII
Bari
- Not yet recruiting
Policlinico S.Orsola-Malpighi IRCCS
Bologna
- Not yet recruiting
Ospedale Maggiore Carlo Alberto Pizzardi
Bologna, Ì
- Not yet recruiting
Fondazione poliambulanza Brescia
Brescia
- Not yet recruiting
Ospedale Giovanni XXIII
Brescia
- Not yet recruiting
Ospedale di Campobasso
Campobasso
- Not yet recruiting
Ospedale Camposampiero
Camposampiero
- Not yet recruiting
Ospedale di Esine asst Valcamonica
Esine
- Not yet recruiting
Ospedale di Feltre (AULSS 1 Dolomiti)
Feltre
- Recruiting
Immunology Laboratory Meyer Children's Hospital IRCCS
Florence
Chiara Azzari, MD, 00390555662542
- Not yet recruiting
Ospedale Morgagni
Forlì
- Not yet recruiting
AO Salvini di Garbagnate
Garbagnate
- Not yet recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASU GI)
Gorizia
- Not yet recruiting
Ospedale di Magenta
Magenta
- Not yet recruiting
Azienda Ospedaliera Policlinico Universitario "G. Martino"
Messina
- Not yet recruiting
IRCCS San Raffaele
Milan
- Not yet recruiting
AORN Santobono
Naples
- Not yet recruiting
AOU Federico II di Napoli
Naples
- Not yet recruiting
Ospedale di Novara
Novara
- Not yet recruiting
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia
- Not yet recruiting
Ospedale spirito santo di Pescara
Pescara
- Not yet recruiting
Azienda sanitaria Friuli occidentale
Pordenone
- Not yet recruiting
Ospedale di Macerata
Province of Macerata
- Not yet recruiting
Ospedale degli infermi
Rimini
- Not yet recruiting
Ospedale Pediatrico Bambin Gesù IRCCS
Roma
- Not yet recruiting
Ospedale Sandro Pertini
Roma
- Not yet recruiting
Ospedale San Leonardo di Salerno
Salerno
- Not yet recruiting
Ospedale di Saronno
Saronno
- Not yet recruiting
AOU Sassari
Sassari
- Not yet recruiting
Ospedale di Scorrano
Scorrano
- Not yet recruiting
ASP Trapani
Trapani
- Not yet recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste
- Not yet recruiting
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine
- Not yet recruiting
Azienda ospedaliera universitaria integrata Verona
Verona
- Not yet recruiting
Ospedale civile di Vibo Valentia
Vibo Valentia
About this study
Official title: 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.
Read the 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.
- Conditions
- Invasive Bacterial Diseases (IBD)
- Being tested
- assessment of pathogens in blood specimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of pathogens in blood specimensDiagnostic test
Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: assessment of pathogens in blood specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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.
Describe the distribution of circulating serogroups/serotypes
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start9 Dec 2021
- Primary completion30 Dec 2031 (estimated)
- Study completion30 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Bacterial Diseases (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Azzari, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322290
- Sponsor's protocol ID
- SEMBAI
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Invasive Bacterial Diseases (IBD)
- ClinicalTrials.gov ID
- NCT06322290
- Acronym / sponsor ID
- SEMBAI
- Conditions
- Invasive Bacterial Diseases (IBD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Mar 2032 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases | – | Diagnostic Test: assessment of pathogens in blood specimensPediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases, as defined in the Italian Superior Institute of Health (ISS) protocol. |
Who may qualify
- Ages
- 1 day to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus Infective bacterial disease in Italy
Key inclusion criteria (1 listed)
- Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI
Key exclusion criteria (1 listed)
- Other type of bacterial infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of pathogens in blood specimensMolecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae | Diagnostic test | pneumococcal, meningococcal, and hemophilus Invasive Bacterial Diseases |
Primary outcome
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.
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)
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
3 secondary outcomes
Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae.
Time frame: 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
Time frame: Through study completion, an average of 1 yeary
Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae.
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Invasive Bacterial Diseases (IBD)
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Bacterial Diseases (IBD), run by Meyer Children's Hospital IRCCS at 38 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Azzari, MD (00390555662542, chiara.azzari@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.