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Enrolling by invitation NCT04178915

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

— Observational Sepsis Infective Endocarditis Pneumonia, Bacterial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bood leukocyte subsets, The cholesterol content of the cell membrane of T-cells and monocytes.
Who it may be relevant to
Registry conditions: Sepsis, Infective Endocarditis, Pneumonia, Bacterial. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belarus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

* 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).

Interventions

  • 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

Primary outcome measures

  • Survival rate [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Belarus · 1 center
  • The Republican Research and Practical Center for Epidemiology and Microbiology — Minsk

Identifiers

NCT: NCT04178915 · RRPCEM_bacterial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗