Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium (STREPTO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Otitis Media; Sinusitis Bacterial

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 Type: Observational
• Enrollment (Anticipated): 3600

Contacts and Locations

• Study Contact: Name: Pieter-Jan Ceyssens, PhD; Phone Number: +32 02 373 31 19; Email: pieter-jan.ceyssens@sciensano.be
• Study Contact Backup: Name: Ioannis Passaris, PhD; Phone Number: +32 02 373 33 23; Email: ioannis.passaris@sciensano.be

Study Locations

• Belgium
  • Brussels, Belgium, 1180
    • Recruiting
    • Sciensano
    • Contact: Pieter-Jan Ceyssens, PhD; Phone Number: +32 02 373 31 19; Email: pieter-jan.ceyssens@sciensano.be
    • Contact: Ioannis Passaris, PhD; Phone Number: +32 02 373 33 23; Email: ioannis.passaris@sciensano.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from non-invasive pneumococcal disease (diagnosed as CAP, sinusitis and otitits media) and living in Belgium at the time of the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns).	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.	September 2020-May 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates.	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.	September 2020-May 2025

Collaborators and Investigators

• Sponsor: Sciensano
• Collaborators: Merck Sharp & Dohme LLC; Pfizer; Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Pieter-Jan Ceyssens, PhD, Sciensano

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Ear Diseases; Paranasal Sinus Diseases; Nose Diseases; Pneumonia, Bacterial; Otitis; Pneumococcal Infections; Pneumonia; Sinusitis; Pneumonia, Pneumococcal; Otitis Media
• Other Study ID Numbers: STREPTO1.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No