Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection. (pVax)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Invasive Pneumococcal Infection

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Stefania Piconi, MD; Phone Number: 0341-489890; Email: s.piconi@asst-lecco.it
• Study Contact Backup: Name: Silvia Pontiggia; Phone Number: 0341-253678; Email: s.pontiggia@asst-lecco.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with positive urinary antigen for S. pneumoniae as the only microbiological finding;
• Patients whose vaccination history or vaccination records are not available.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019.	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 Outcome Measures

Outcome Measure	Time Frame
Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event	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.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Lecco
• Collaborators: IRCCS Ospedale San Raffaele
• Investigators: Principal Investigator: Antonella Castagna, Prof, IRCCS Ospedale San Raffaele Turro - Milano Infectious Diseases Unit

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Infections; Communicable Diseases; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: pVax

Drug and device information, study documents

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