PneumoniaSTREPTONCT04447521
Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
An observational study of Pneumonia and Otitis Media, run by Sciensano at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Otitis Media, Sinusitis Bacterial
- How many people
- 1,404 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 10 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually sterile specimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 20-months Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium to Evaluate National Vaccination Strategy
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.
Read the detailed 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.
- Conditions
- Pneumonia, Otitis Media, Sinusitis Bacterial
- Medical subject headings
- Pneumonia, Otitis Media
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: September 2020-May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Sep 2020
- Primary completion1 May 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Pfizer, Merck Sharp & Dohme LLC, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Pieter-Jan Ceyssens, PhD, Principal investigator, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447521
- Sponsor's protocol ID
- STREPTO1.2
- Acronym
- STREPTO
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No