Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

NCT ID: NCT04178915

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-12-31

Brief Summary

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Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.

Detailed Description

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* To study the state of the immune system in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis): spontaneous and stimulated production of reactive oxygen species by blood neutrophils; spontaneous necroptosis, apoptosis and pyroptosis of neutrophils; the content of blood leukocyte subpopulations.
* Assess the clinical, biochemical status, state of the lipid transport system of patients with severe bacterial infections (in the model of pneumonia, infective endocarditis, sepsis), including determination of the cholesterol content in the cell membrane of T-cells and monocytes.
* To develop a method for predicting an unfavorable course and an algorithm for the treatment (immunocorrection) of severe bacterial infections (on the model of pneumonia, infectious endocarditis, sepsis) based on the determination of the clinical and immunological status, indicators of the lipid transport system and dysmetabolic disorders, and propose a correction method for the treatment of these diseases, supplementing existing clinical protocols (preparations of immunoglobulins, lipids for parenteral nutrition, possibly PCSK9 inhibitors).

Conditions

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Sepsis Infective Endocarditis Pneumonia, Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with severe bacterial infections

Bood leukocyte subsets

Intervention Type DIAGNOSTIC_TEST

Determination of blood leukocyte subpopulations, myeloid suppressor cells of various origins, type 2 congenital lymphoid cells, depleted T cells, CD45RA+ CD45RB+ CD62L-IRC, T-cell differentiation stages (naive - memory cells - effector - terminally differentiated effectors), B cells (CD5+ B1 cells, CD11c+ ABC, differentiation stages: immature - naive - isotype-unswitched memory cells - isotype-switched memory cells - plasmoblast)

The cholesterol content of the cell membrane of T-cells and monocytes

Intervention Type DIAGNOSTIC_TEST

The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis

Interventions

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Bood leukocyte subsets

Determination of blood leukocyte subpopulations, myeloid suppressor cells of various origins, type 2 congenital lymphoid cells, depleted T cells, CD45RA+ CD45RB+ CD62L-IRC, T-cell differentiation stages (naive - memory cells - effector - terminally differentiated effectors), B cells (CD5+ B1 cells, CD11c+ ABC, differentiation stages: immature - naive - isotype-unswitched memory cells - isotype-switched memory cells - plasmoblast)

Intervention Type DIAGNOSTIC_TEST

The cholesterol content of the cell membrane of T-cells and monocytes

The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA\> 2);
* the patient's ability to comply with the instructions of the research doctor and follow the procedures required by the test protocol;
* informed consent.

Exclusion Criteria

* acute and chronic heart failure;
* renal failure;
* acute and chronic liver failure;
* taking medications of the statin group during the last month before the study;
* diabetes in the stage of clinical and metabolic decompensation;
* acute and chronic leukemia, severe anemia;
* pregnancy or lactation;
* HIV infection;
* drug addiction;
* immunosuppressive therapy;
* malignant neoplasms over the past 5 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Fomina, Dr

Role: PRINCIPAL_INVESTIGATOR

Head of the laboratory, RSPCEM

Locations

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The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_bacterial

Identifier Type: -

Identifier Source: org_study_id

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