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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sepsis; Pneumonia, Bacterial; Infective Endocarditis
• Intervention / Treatment: Diagnostic test: Bood leukocyte subsets; Diagnostic test: The cholesterol content of the cell membrane of T-cells and monocytes

Detailed Description

• 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).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220114
    • The Republican Research and Practical Center for Epidemiology and Microbiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute bacterial infections

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);
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with severe bacterial infections

Diagnostic test: 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival rate	1 month

Collaborators and Investigators

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
• Collaborators: Belarusian State Medical University
• Investigators: Principal Investigator: Elena Fomina, Dr, Head of the laboratory, RSPCEM

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis; Bacterial Infections; Pneumonia, Bacterial; Endocarditis, Bacterial
• Other Study ID Numbers: RRPCEM_bacterial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No