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Completed

NCT Number: NCT04447521

Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

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.

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Key information

Conditions

Pneumonia Ear Diseases Infections Lung Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis Bacterial

Sex eligibility

All sexes

Study type

Observational

Primary location

Sciensano

Brussels, 1180, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sciensano

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC
  • Pfizer
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Acronym: STREPTO

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2020
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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