Algorithm for Predicting the Unfavorable Course of Sepsis in Children

December 9, 2025 updated by: E.G.Fomina, The Republican Research and Practical Center for Epidemiology and Microbiology

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

A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.).

Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.

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

  • analyze biochemical markers and immune status data in sepsis patients and in the comparison group;
  • assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients;
  • carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome);
  • assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process;
  • based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.

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.
Observational

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.
185

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Oksana N Romanova, Dr
  • Phone Number: +375172022505
  • Email: romox@tut.by

Study Contact Backup

  • Name: Elena G Fomina, Dr
  • Phone Number: +375173730417
  • Email: feg1@tut.by

Study Locations

  • Belarus
      • Minsk, Belarus
        • City Children's Infectious Clinical Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • age from 1 month to 18 years;
  • confirmed septic process$
  • informed consent.

Exclusion Criteria:

  • age from 18 years;
  • refuse of patient to participate in the trial;
  • chronic mental disorders with severe manifestations;
  • pregnancy/lactation;
  • intercurrent severe chronic diseases;
  • HIV, Hepatites B/C;
  • active tuberculosis;
  • cachexia of any origin;
  • 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients with sepsis on day 1
Diagnostic test: Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
Other Names:
  • assessment of genetic polymorphism
Patients with sepsis on day 7
Diagnostic test: Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
Other Names:
  • assessment of genetic polymorphism
Patients with severe bacterial infection
Patients with severe bacterial infection (pneumonia)
Diagnostic test: Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
Other Names:
  • assessment of genetic polymorphism
Patients with severe viral infection
Patients with severe viral infection (COVID19)
Diagnostic test: Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
Other Names:
  • assessment of genetic polymorphism

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
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
Time Frame: 1 month

Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes).

Leucocyte count was determined under a microscope in a Goryaev chamber.
1 month
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
Time Frame: 1 month

Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)).

Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0.
1 month

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 Republican Research and Practical Center for Epidemiology and Microbiology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Belarusian State Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elena G Fomina, Dr, The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)

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.
July 1, 2021

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.
December 25, 2024

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 1, 2025

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).
May 30, 2023

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.
June 8, 2023

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.
June 18, 2023

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.
December 30, 2025

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.
December 9, 2025

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.
December 1, 2025

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.
  • RRPCEM_SEPSIS

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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