Invasive Pneumococcal InfectionpVaxNCT06334185
Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection.
An observational study of Invasive Pneumococcal Infection, run by Azienda Ospedaliera di Lecco.
Trial summary
Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Pneumococcal Infection
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2024to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective multicenter study is planned on patients admitted to the Alessandro Manzoni Hospital in Lecco and the San Raffaele Hospital in Milan with a diagnosis of systemic pneumococcal infection from 01/01/2015 to 12/31/2019 before the SARS pandemic -CoV-2. All patients admitted with a diagnosis of invasive pneumococcal infection defined by positive blood or CSF cultures for S. pneumoniae by the microbiology laboratory were enrolled.
Who may be able to join
- Patients over 18 years old;
- Patients hospitalized at the Manzoni Hospital in Lecco or at the San Raffaele Hospital in Milan with invasive pneumococcal infection in the period between 01/01/2015 and 31/12/2019;
- Presence of a positive culture test for S. pneumoniae on blood cultures and/or liquor;
- Patients whose discharge letter or clinical documentation relating to the infectious episode is available;
- Patients whose vaccination record can be consulted (on paper or on SIAVR) and whose vaccination history is available before and after hospitalization.
Who cannot join
- Patients with positive urinary antigen for S. pneumoniae as the only microbiological finding;
- Patients whose vaccination history or vaccination records are not available.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection: a Retrospective Study in Two Lombardy Centers in the Pre-pandemic Phase From 2015 to 2019.
Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.
However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis.
- Conditions
- Invasive Pneumococcal Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019.
Measured: The information regarding vaccination after the infectious episode will be assessed by consulting the SIAVR portal or the vaccination booklet in a period between at least one month from discharge and up to 06/30/2023.
Secondary outcomes (1)
Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event
Measured: The information regarding vaccination after the infectious episode will be assessed by consulting the SIAVR portal or the vaccination booklet in a period between at least one month from discharge and up to 06/30/2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start31 May 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pneumococcal InfectionStudies 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
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Lecco
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele
- Responsible party
- Principal investigator, Stefania Piconi, Azienda Ospedaliera di Lecco
- Investigators
- Antonella Castagna, Prof, Principal investigator, IRCCS Ospedale San Raffaele Turro - Milano Infectious Diseases Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334185
- Sponsor's protocol ID
- pVax
- Acronym
- pVax
- Status last verified
- May 2024
- First submitted
- 20 Mar 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection: a Retrospective Study in Two Lombardy Centers in the Pre-pandemic Phase From 2015 to 2019.
- ClinicalTrials.gov ID
- NCT06334185
- Acronym / sponsor ID
- pVax / pVax
- Conditions
- Invasive Pneumococcal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di LeccoUniversity, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 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.
Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.
However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective multicenter study is planned on patients admitted to the Alessandro Manzoni Hospital in Lecco and the San Raffaele Hospital in Milan with a diagnosis of systemic pneumococcal infection from 01/01/2015 to 12/31/2019 before the SARS pandemic -CoV-2. All patients admitted with a diagnosis of invasive pneumococcal infection defined by positive blood or CSF cultures for S. pneumoniae by the microbiology laboratory were enrolled.
Key inclusion criteria (5 listed)
- Patients over 18 years old;
- Patients hospitalized at the Manzoni Hospital in Lecco or at the San Raffaele Hospital in Milan with invasive pneumococcal infection in the period between 01/01/2015 and 31/12/2019;
- Presence of a positive culture test for S. pneumoniae on blood cultures and/or liquor;
- Patients whose discharge letter or clinical documentation relating to the infectious episode is available;
- Patients whose vaccination record can be consulted (on paper or on SIAVR) and whose vaccination history is available before and after hospitalization.
Key exclusion criteria (2 listed)
- Patients with positive urinary antigen for S. pneumoniae as the only microbiological finding;
- Patients whose vaccination history or vaccination records are not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019.
Time frame: The information regarding vaccination after the infectious episode will be assessed by consulting the SIAVR portal or the vaccination booklet in a period between at least one month from discharge and up to 06/30/2023.
1 secondary outcome
Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event
Time frame: The information regarding vaccination after the infectious episode will be assessed by consulting the SIAVR portal or the vaccination booklet in a period between at least one month from discharge and up to 06/30/2023.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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. This study is not recruiting at the moment.
Antonella Castagna, Prof principal investigator
IRCCS Ospedale San Raffaele Turro - Milano Infectious Diseases Unit
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pneumococcal Infection, run by Azienda Ospedaliera di Lecco.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Piconi, MD (0341-489890, s.piconi@asst-lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019. (time frame: The information regarding vaccination after the infectious episode will be assessed by consulting the SIAVR portal or the vaccination booklet in a period between at least one month from discharge and up to 06/30/2023.). 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 May 2024.