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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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