Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

NCT ID: NCT04447521

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia Otitis Media Sinusitis Bacterial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

Sciensano

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pieter-Jan Ceyssens, PhD

Role: PRINCIPAL_INVESTIGATOR

Sciensano

Locations

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Sciensano

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Pieter-Jan Ceyssens, PhD

Role: CONTACT

02 373 31 19 ext. +32

Ioannis Passaris, PhD

Role: CONTACT

02 373 33 23 ext. +32

Facility Contacts

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Pieter-Jan Ceyssens, PhD

Role: primary

02 373 31 19 ext. +32

Ioannis Passaris, PhD

Role: backup

02 373 33 23 ext. +32

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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STREPTO1.2

Identifier Type: -

Identifier Source: org_study_id

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