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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06334185
Other study ID # pVax
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 31, 2024
Est. completion date July 1, 2024

Study information

Verified date May 2024
Source Azienda Ospedaliera di Lecco
Contact Stefania Piconi, MD
Phone 0341-489890
Email s.piconi@asst-lecco.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 320
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliera di Lecco IRCCS Ospedale San Raffaele

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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