To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers

November 15, 2023 updated by: The Republican Research and Practical Center for Epidemiology and Microbiology
Current study evaluates the relationship between cell immunity, biochemical and genetic markers in patients with sepsis in order to develop algorithm for predicting the course and outcome of severe bacterial infections.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • To study the state of the immune system in patients with sepsis: the content of blood monocyte subpopulations (classical, intermediate and non-classical monocytes), HLA-DR expression on monocytes, CD64 expression on neutrophils, spontaneous and stimulated production of reactive oxygen species by blood neutrophils etc.;
  • To study biochemical blood parameters and genetic polymorphism of immune response genes;
  • To evaluate the relationship between genetic features of the patient's immune system, biochemical blood parameters, immune system cells and the severity of the pathological process.
  • To develop an algorithm to prevent the development of sepsis in children.

Study Type

Observational

Enrollment (Estimated)

124

Contacts and Locations

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

Study Contact

  • Name: Elena G Fomina, Dr
  • Phone Number: +375173430417
  • Email: feg1@tut.by

Study Locations

  • Belarus
      • Minsk, Belarus, 220114
        • Recruiting
        • Republican Research and Practical Centre for Epidemiology and Microbiology
        • Contact:
          • Elena G Fomina, Dr
          • Phone Number: +375173430417
          • Email: feg1@tut.by
        • Sub-Investigator:
          • Ekaterina N Sergeenko, PhD

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with severe viral infection, with severe bacterial infection, with sepsis on day 1, with sepsis on day 7 and healthy children

Description

Inclusion Criteria:

community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2); availability of written informed consent of the patient's legal representatives for the study.

Exclusion Criteria:

acute and chronic heart failure; renal failure; acute and chronic liver failure; acute and chronic leukemia, severe anemia; HIV infection; immunosuppressive therapy; malignant neoplasms

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
healthy children
Diagnostic test: flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
Diagnostic test: ELISA
estimation of the TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
Diagnostic test: RFLP
assessment of polymorphism TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique
sepsis-1
children with sepsis on the 1 day
Diagnostic test: flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
Diagnostic test: ELISA
estimation of the TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
Diagnostic test: RFLP
assessment of polymorphism TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique
sepsis-7
children with sepsis on the 7 day
Diagnostic test: flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
Diagnostic test: ELISA
estimation of the TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
Diagnostic test: RFLP
assessment of polymorphism TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique
severe bacterial infection
children with severe bacterial infection
Diagnostic test: flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
Diagnostic test: ELISA
estimation of the TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
Diagnostic test: RFLP
assessment of polymorphism TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique
severe viral infection
children with severe viral infection
Diagnostic test: flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
Diagnostic test: ELISA
estimation of the TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
Diagnostic test: RFLP
assessment of polymorphism TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monocytes
Time Frame: 3 years
proportion of classical monocytes (CD14++CD16-), intermediate monocytes (CD14++CD16+) and non-classical monocytes (CD14+/-CD16++); HLA-DR level of expression
3 years
neutrophils
Time Frame: 3 years
percentage of CD64+ neutrophils and CD64 level of expression
3 years
cytokines levels in the serum
Time Frame: 3 years
TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
3 years
genes polymorphism
Time Frame: 3 years
TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes polymorphism
3 years

Collaborators and Investigators

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

Sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Collaborators

Belarusian State Medical University

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)

July 1, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

results of the determination of monocytes subpopulations (classical, intermediate and non-classical) in the blood of patients, of HLA-DR expression on monocytes, CD64 expression on neutrophils; assessment of genetic predisposition to sepsis; cytokines levels in serum

IPD Sharing Time Frame

June 30, 2024 for 1 year

IPD Sharing Supporting Information Type

  • CSR

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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