Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

NCT04447521

Last updated date
Study Location
Sciensano
Brussels, , 1180, Belgium
Contact
02 373 31 19

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia, Otitis Media, Sinusitis Bacterial
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Pneumonia, Otitis Media, Sinusitis BacterialSurveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
NCT04447521
  1. Brussels,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Official Title A 20-months Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium to Evaluate National Vaccination Strategy
Brief Summary We 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 We will conduct a 20-months (September 2020-May 2020) 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 Sciensano. Sciensano will determine the serotype and the antibiotic resistance profile of these clinical isolates. Whole genome seuqencing will be performed on a subset of these isolates.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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.
Condition
  • Pneumonia
  • Otitis Media
  • Sinusitis Bacterial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 22, 2020)
3600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pieter-Jan Ceyssens, PhD02 373 31 19 ext +32[email protected]
Contact: Ioannis Passaris, PhD02 373 33 23 ext +32[email protected]
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04447521
Other Study ID Numbers STREPTO1.2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sciensano
Study Sponsor Sciensano
Collaborators
  • Pfizer
  • Merck Sharp & Dohme Corp.
  • Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator:Pieter-Jan Ceyssens, PhDSciensano
PRS Account Sciensano
Verification Date March 2020