SepsisNCT04178915
Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections
An observational study of Sepsis and Infective Endocarditis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis, Infective Endocarditis, Pneumonia, Bacterial
- What is being tested?
- Bood leukocyte subsets and The cholesterol content of the cell membrane of T-cells and monocytes
- How many people
- 100 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Patients with acute bacterial infections
Who may be able to join
- 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.
Who cannot join
- 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;
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- pregnancy or lactation;
- HIV infection;
- drug addiction;
- immunosuppressive therapy;
- malignant neoplasms over the past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site
The Republican Research and Practical Center for Epidemiology and Microbiology
Minsk, 220114
About this study
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).
- Conditions
- Sepsis, Infective Endocarditis, Pneumonia, Bacterial
- Being tested
- Bood leukocyte subsets, The cholesterol content of the cell membrane of T-cells and monocytes
- Medical subject headings
- Sepsis, Endocarditis, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bood leukocyte subsetsDiagnostic 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)
The cholesterol content of the cell membrane of T-cells and monocytesDiagnostic test
The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe bacterial infections | Not described Receives: Diagnostic Test: Bood leukocyte subsets; Diagnostic Test: The cholesterol content of the cell membrane of T-cells and monocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Elena Fomina, Dr, Principal investigator, Head of the laboratory, RSPCEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178915
- Sponsor's protocol ID
- RRPCEM_bacterial
- Status last verified
- Feb 2025
- First submitted
- 24 Nov 2019
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections
- ClinicalTrials.gov ID
- NCT04178915
- Acronym / sponsor ID
- RRPCEM_bacterial
- Conditions
- Sepsis, Infective Endocarditis, Pneumonia, Bacterial
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe bacterial infections | – | Diagnostic Test: Bood leukocyte subsets, Diagnostic Test: The cholesterol content of the cell membrane of T-cells and monocytes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with acute bacterial infections
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bood leukocyte subsetsDetermination 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 test | Patients with severe bacterial infections |
| The cholesterol content of the cell membrane of T-cells and monocytesThe cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis | Diagnostic test | Patients with severe bacterial infections |
Primary outcome
Survival rate
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Fomina, Dr principal investigator
Head of the laboratory, RSPCEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infective Endocarditis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.