Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
NCT04447521
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Adult Trials: 18+ Years
- 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.
• Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually
sterile specimen
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| 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 |
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| 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 | 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:
Exclusion Criteria: ? Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually sterile specimen | ||||||||
| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Sciensano | ||||||||
| Study Sponsor | Sciensano | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Sciensano | ||||||||
| Verification Date | March 2020 | ||||||||