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

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The Republican Research and Practical Center for Epidemiology and Microbiology

Status

Invitation-only

Conditions

Infective Endocarditis
Pneumonia, Bacterial
Sepsis

Treatments

Diagnostic Test: The cholesterol content of the cell membrane of T-cells and monocytes
Diagnostic Test: Bood leukocyte subsets

Study type

Observational

Funder types

Other

Identifiers

NCT04178915
RRPCEM_bacterial

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients with severe bacterial infections
Treatment:
Diagnostic Test: Bood leukocyte subsets
Diagnostic Test: The cholesterol content of the cell membrane of T-cells and monocytes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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