Clinical trial NCT04178915: Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections
Official title: Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sepsis
Infective Endocarditis
Pneumonia, Bacterial
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
Collaborators: name: Belarusian State Medical University
First posted: 2019-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute bacterial infections

Brief summary: 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).

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.

Primary outcomes:
measure: Survival rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: The Republican Research and Practical Center for Epidemiology and Microbiology
Study officials:
affiliation: Head of the laboratory, RSPCEM
name: Elena Fomina, Dr
role: PRINCIPAL_INVESTIGATOR
References: