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

February 8, 2021 updated by: Roman Kozlov, The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, disease severity, geographic region, and over time. Infants and young children are thought to be the main reservoir of this agent. From the colonized nasopharyngeal mucosa, pneumococci may spread by contiguous, non-invasive extension to other sites in the respiratory tract.

About 1.6 million cases of fatal pneumococcal disease occur worldwide annually, mostly in infants and the elderly.3 In addition, immunocompromised individuals of all ages, immunocompetent patients with concomitant diseases (chronic heart failure, broncho-obstructive syndrome, liquorrhea, ext.) are at increased risk.

Pneumococcal resistance to commonly used antimicrobials is a serious and increasing problem worldwide. Therefore vaccination is the most effective mechanism to reduce the incidence of pneumococcal infection in children and adult patients.

The effectiveness of pneumococcal vaccine is estimated by coverage of serotypes of S. pneumoniae. The distribution of the serotypes can be potentoinally changed because of the using of PCV in Russia.

Study design. Prospective Multicentre Microbiological study.

General informed consents are collected from patients at hospital admission. No additional informed consents will be collected for this study since the procedures of microbiological sample collection will be performed as a part of standard medical aid practices. Patient confidentiality will be retained at all times, and patient identifiers will not be included in the study. Collection of strains will be performed in patients, who meet inclusion criteria.

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.
  • 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 protocol.

Study procedures:

  • collection of strains of S. pneumoniae and identification - the participating laboratory will collect, identify and store isolates and submit to reference laboratory of the Institute of Antimicrobial Chemotherapy of Smolensk State Medical University only clinical isolates that meet the study criteria as defined by protocol. Each isolate must be accompanied by a Organisms Report Form (ORF). The ORF contains information regarding the demographics of each isolate. Each investigative site will provide complete isolate identification using the laboratory's routine procedures.
  • re-identification of strains of S. pneumoniae in the central laboratory (IAC, Smolensk) - at least, 500 consecutive non-duplicate strains of S. pneumoniae from healthy carriage and patients with non-invasive and invasive pneumococcal infections will be analyzed in centers from the following locations: Central region, North-Western region, Ural, Southern region, Siberia, Far-Eastern region. All the strains will be initially re-identified to the species level at the IAC laboratory using classic bacteriologic methods and MALDI Biotyper.
  • susceptibility testing - susceptibility testing to penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin will be determined by broth microdilution method. Interpretation will be done according to EUCAST/CLSI.
  • serotyping (LATEX-TEST, Real-time PCR) - serotyping of S. pneumoniae will be performed using PNEUMOTEST-LATEX TEST and Real-Time PCR.
  • data analysis
  • reporting Strains collection: 01.06.2019 - 30.01.2020

Laboratory procedures:

  1. Re-identification: till 31.10.2019
  2. Antimicrobial susceptibility testing: till 01.06.2020
  3. Serotyping: till 31.05.2020 Data analysis and reporting: till 28.02.2021 This is a non-interventional database study based on secondary use of data collected for other purposes. No administration of any therapeutic or prophylactic agent is required in this protocol. No reporting of individual adverse events to regulatory agencies is planned for this database study because there is no access to individual patient/subject records and it is not possible to assess the causality of individual cases. Pre-specified health outcomes of interest, including any that qualify as adverse events, will be summarized as part of any interim analysis (including safety analysis, if required) and in the final study report, which will be provided to regulatory agencies by the sponsor as required.

Any relevant safety information will be summarized in the appropriate Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER) and/or Development Safety Update Reports (DSUR) if required.

If an investigator elects to spontaneously report any suspected adverse reactions, they should be reported via fax to Merck AER Mailbox FAX #215-661-6229 (US), or toll-free fax 1-800-547-5552 (ex-US and US availability), in English using an AE form (attached) for reporting to worldwide regulatory agencies as appropriate

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Smolensk, Russian Federation, 214019
        • The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinically relevant causative isolate - The isolate must meet the laboratory criteria of S. pneumoniae and be considered the "probable causative agent" of infection.
  2. Isolates from patients older 18-years with pneumococcal acute otitis media
  3. Isolates from patients older 18-years with pneumococcal pneumonia
  4. Isolates from patients older 18-years with invasive pneumococcal diseases (meningitis, sepsis)
  5. Isolates from healthy carriage older 18-years

Exclusion Criteria:

  1. Isolates that have been collected and/or stored prior to June 1, 2018 or later than September 30, 2019.
  2. Duplicate isolates (same genus and species) obtained at any subsequent time from the same patient, regardless of susceptibility or phenotypic profile.
  3. Environmental samples (non patient-derived) or surveillance cultures taken for infection control purposes.
  4. Outside study group - Any isolate other than those defined by the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with pneumococcal infection
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
There will be detection of Streptococcus pneumoniae, serotype identification, susceptibility tests for penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of pneumococcal infection in the Russian Federation, caused by different serotypes of Streptococcus pneumoniae
Time Frame: 1 year
The incidence will be detected with descriptive statistics
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of antimicrobial resistance of serotypes of Streptococcus pneumoniae
Time Frame: 1 year
Detection of antimicrobial resistance to penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin will be detected with descriptive statistics
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IAC-SPECTRUM-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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