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

Обзор

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.

Подробное описание

* 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).

Вмешательства

• Диагностический тест 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)
• Диагностический тест 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

Первичные конечные точки

• Survival rate [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Беларусь · 1 центр

• The Republican Research and Practical Center for Epidemiology and Microbiology — Minsk

Идентификаторы

NCT: NCT04178915 · RRPCEM_bacterial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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