An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in… (NCT04464291) | Clinical Trial Compass
CompletedNot Applicable
An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years
Russia500 participantsStarted 2019-06-01
Plain-language summary
Pneumococcal conjugate vaccine was added to the National Immunization Program in Russia in 2014 which could affect the changes in pneumococcal serotypes in growing population. The purpose of this study is to determine the spectrum of serotypes of S. pneumoniae in patients older 18-years: in healthy carriage, in patients with non-invasive and invasive forms of pneumococcal infection. The patients will be divide into several groups: 18-64-years old, 65 years old and older, immunocompromised patients, immunocompetent patients with concomitant diseases and patients from restricted organized collectives.
This study is designed to meet the following objectives:
To estimate the spectrum of serotypes of S. pneumoniae in adult population in different regions of Russia.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Clinically relevant causative isolate - The isolate must meet the laboratory criteria of S. pneumoniae and be considered the "probable causative agent" of infection.
✓. Isolates from patients older 18-years with pneumococcal acute otitis media
✓. Isolates from patients older 18-years with pneumococcal pneumonia
✓. Isolates from patients older 18-years with invasive pneumococcal diseases (meningitis, sepsis)
✓. Isolates from healthy carriage older 18-years
Exclusion criteria
✕. Isolates that have been collected and/or stored prior to June 1, 2018 or later than September 30, 2019.
✕. Duplicate isolates (same genus and species) obtained at any subsequent time from the same patient, regardless of susceptibility or phenotypic profile.
✕. Environmental samples (non patient-derived) or surveillance cultures taken for infection control purposes.
✕
What they're measuring
1
Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae
Timeframe: 1 year
Trial details
NCT IDNCT04464291
SponsorThe Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)