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

NCT04178915 | Enrolling By Invitation

• 1 other identifier: RRPCEM_bacterial
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Infective Endocarditis; Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

• Survival rate

  1 month

Study Arms (1)

Patients with severe bacterial infections

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

Interventions

Bood leukocyte subsets DIAGNOSTIC_TEST

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)

Patients with severe bacterial infections

The cholesterol content of the cell membrane of T-cells and monocytes DIAGNOSTIC_TEST

The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis

Patients with severe bacterial infections

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute bacterial infections

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Republican Research and Practical Center for Epidemiology and Microbiology: lead
• Belarusian State Medical University: collaborator

Study Sites (1)

The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, 220114, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Heparinized whole blood

MeSH Terms

Conditions

Sepsis; Endocarditis; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elena Fomina, Dr

  Head of the laboratory, RSPCEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

BE (1)