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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04464291
Other study ID # IAC-SPECTRUM-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date January 31, 2021

Study information

Verified date February 2021
Source The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Detection of Streptococcus pneumoniae strains
There will be detection of Streptococcus pneumoniae, serotype identification, susceptibility tests for penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin

Locations

Country Name City State
Russian Federation The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy Smolensk

Sponsors (1)

Lead Sponsor Collaborator
The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae The incidence will be detected with descriptive statistics 1 year
Secondary Incidence of antimicrobial resistance of serotypes of Streptococcus pneumoniae Detection of antimicrobial resistance to penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin will be detected with descriptive statistics 1 year
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