Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

Recruiting

• Conditions: Pneumonia; Otitis Media; Sinusitis Bacterial

• Registration Number: NCT04447521
• Lead Sponsor: Sciensano

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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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	To date, little is known about serotype distribution in NIPD and how this relate with the more widely studied serotype distribution in IPD. This study aims to shed light onto this topic.

Trial Locations

Locations (1)

Sciensano; 🇧🇪 Brussels, Belgium