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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04178915
Other study ID # RRPCEM_bacterial
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2023

Study information

Verified date November 2023
Source The Republican Research and Practical Center for Epidemiology and Microbiology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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)
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

Locations

Country Name City State
Belarus The Republican Research and Practical Center for Epidemiology and Microbiology Minsk

Sponsors (2)

Lead Sponsor Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate 1 month
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