An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years

NCT04464291 | Completed

• 1 other identifier: IAC-SPECTRUM-2019
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 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

Keywords

Serotype; Streptococcus pneumoniae; Epidemiology; Antmicrobial resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of antimicrobial resistance of serotypes of Streptococcus pneumoniae

  1 year

Study Arms (1)

Patients with pneumococcal infection

EXPERIMENTAL

There will be assessing the prevalence of Streptococcus pneumoniae serotypes in the nasopharynx in healthy people; in middle ear liquid in patients with acute otitis media; in sputum and epithelial lining fluid in patients with community-acquired pneumonia; in spinal fluid in patients with invasive pneumococcal indection

Other: Detection of Streptococcus pneumoniae strains

Interventions

Detection of Streptococcus pneumoniae strains OTHER

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

Patients with pneumococcal infection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC): lead

Study Sites (1)

The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy

Smolensk, 214019, Russia

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Otitis Media

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: Prospective Multicentre Microbiological study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: July 9, 2020
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: January 31, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)