STREPTO: Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

Sponsor

Sciensano (Other)

Overall Status

Recruiting

CT.gov ID

NCT04447521

Collaborator

Pfizer (Industry), Merck Sharp & Dohme LLC (Industry), Universitaire Ziekenhuizen Leuven (Other)

3,600

Enrollment

Location

Anticipated Duration (Months)

128.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Otitis Media Sinusitis Bacterial

Detailed Description

The investigators will conduct a 20-months (September 2020-May 2022) surveillance of non-invasive S. pneumoniae infections in Belgium. 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 Design

Study Type:

Observational

Anticipated Enrollment :

3600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns). [20-months (September 2020-May 2022)]
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

Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates. [20-months (September 2020-May 2022)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.