Status:
COMPLETED
An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years
Lead Sponsor:
The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)
Conditions:
Pneumonia, Pneumococcal
Invasive Pneumococcal Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 stud...
Detailed Description
S. pneumoniae is a major cause of illness and death in children and adults worldwide. It includes 91 serotypes. The distribution of serotypes that cause disease varies by age, disease syndrome, diseas...
Eligibility Criteria
Inclusion
- 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
- 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.
- Outside study group - Any isolate other than those defined by the protocol
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04464291
Start Date
June 1 2019
End Date
January 31 2021
Last Update
February 11 2021
Active Locations (1)
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1
The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy
Smolensk, Russia, 214019