Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04447521

Acronym

STREPTO

Enrollment

1404

Registered

2020-06-25

Start date

2020-09-01

Completion date

2025-12-10

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media, Pneumonia, Sinusitis Bacterial

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium

Contacts

PRINCIPAL_INVESTIGATORPieter-Jan Ceyssens, PhD

Sciensano

Outcome results