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Clinical Trials/NCT04447521
NCT04447521
Recruiting
Not Applicable

A 20-months Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium to Evaluate National Vaccination Strategy

Sciensano1 site in 1 country3,600 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Sciensano
Enrollment
3600
Locations
1
Primary Endpoint
Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns).
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The investigators will conduct a prospective observational study of non-invasive S. pneumoniae infections in Belgium and characterize serotype distributions to evaluate national vaccination programs.

Detailed Description

The investigators will conduct a surveillance of non-invasive S. pneumoniae infections in Belgium (September 2020-May 2025). Monthly, 12 peripheral hospitals will send the first 15 unduplicated clinical S. pneumoniae samples (coming from patients diagnosed with pneumonia, otitits media or sinusitis) to the investigators. The investigators will determine the serotype and the antibiotic resistance profile of these clinical isolates. Whole genome sequencing will be performed on a subset of these isolates. From May 2021, 13 extra participating centers have been added to the study.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sciensano
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients living in Belgium at the time of the study,
  • from whom unduplicated S. pneumoniae isolates were collected in routine practices,
  • from non-invasive upper (e.g.: pus/fluid from nasal sinus or from otitis media fluid) or lower respiratory tract (e.g. sputum bronchial or endotracheal aspirate, bronchoalveolar fluid (BAL),...) clinical samples,
  • from patients diagnosed with pneumonia, sinusitis and otitis.

Exclusion Criteria

  • Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually sterile specimen

Outcomes

Primary Outcomes

Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns).

Time Frame: September 2020-May 2025

There is a wealth of information available on the serotype distribution of S. pneumoniae causing inavsive pneumococcal disease (IPD). However, much less is known about the serotype distribution of S. pneumoniae causing non-invasive pneumococcal disease (NIPD). The goal of this study is to characterize the serotype distribution of of S. pneumoniae causing NIPD in Belgium, compare is with IPD data and link it with the changing national vaccinations programs.

Secondary Outcomes

  • Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates.(September 2020-May 2025)

Study Sites (1)

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