Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

NCT04447521 | Unknown DMC

• 1 other identifier: STREPTO1.2
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Otitis Media; Sinusitis Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually sterile specimen

Sponsors & Collaborators

• Sciensano: lead
• Pfizer: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Sciensano

Brussels, 1180, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Streptococcus pneumoniae samples will be collected and stored during the time frame of this study. DNA extraction and whole-genome sequencing will be performed for a subset of these strains.

MeSH Terms

Conditions

Pneumonia; Otitis Media

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Pieter-Jan Ceyssens, PhD

  Sciensano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter-Jan Ceyssens, PhD

CONTACT

02 373 31 19; pieter-jan.ceyssens@sciensano.be

Ioannis Passaris, PhD

CONTACT

02 373 33 23; ioannis.passaris@sciensano.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: September 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

BE (1)