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Enrolling by invitationNCT04178915Updated Feb 11, 2025

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

An observational study in Sepsis, Infective Endocarditis and Pneumonia, Bacterial, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Enrolling by invitation at 1 site in Belarus. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Sepsis
  • Infective Endocarditis
  • Pneumonia, Bacterial
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with acute bacterial infections

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testBood 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)

  • Diagnostic testThe 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

06

What researchers measure

Primary outcomes

  1. Survival rate

    Time frame: 1 month

07

Study locations

1 site
  • The Republican Research and Practical Center for Epidemiology and Microbiology
    Minsk, 220114, Belarus
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04178915
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian State Medical University
Responsible party
Sponsor
First posted
Nov 26, 2019
Start date
Jul 1, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 11, 2025

Study contacts

Elena Fomina, Dr
principal investigator · Head of the laboratory, RSPCEM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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