Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

Pneumonia Clinical Trial

— STREPTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447521
• Other study ID #: STREPTO1.2
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Sciensano
• Contact: Pieter-Jan Ceyssens, PhD
• Phone: 02 373 31 19
• Email: pieter-jan.ceyssens[@]sciensano.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: December 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Otitis Media
• Pneumococcal Infections
• Pneumonia
• Pneumonia, Pneumococcal
• Sinusitis
• Sinusitis Bacterial

Locations

Country	Name	City	State
Belgium	Sciensano	Brussels

Sponsors (4)

Lead Sponsor	Collaborator
Sciensano	Merck Sharp & Dohme LLC, Pfizer, Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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