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
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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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2019-07-01
2025-12-31
Brief Summary
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Detailed Description
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* 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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with severe bacterial infections
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)
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
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)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Belarusian State Medical University
OTHER
The Republican Research and Practical Center for Epidemiology and Microbiology
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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RRPCEM_bacterial
Identifier Type: -
Identifier Source: org_study_id
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