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An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years: Healthy Carriage, Patients With Non-invasive and Invasive Pneumococcal Infections in the Russian Federation

ClinicalTrials.gov · COMPLETED, 2021

500 participants

Abstract

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.

Conditions: Pneumonia, Pneumococcal, Invasive Pneumococcal Disease, Acute Otitis Media.

Primary outcome: Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae.

Enrollment: 500 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 500 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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