SepsisNCT05908162

Algorithm for Predicting the Unfavorable Course of Sepsis in Children

An observational study of Sepsis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 18 yearsHealthy volunteers can take part
Conditions the study is for: Sepsis
What is being tested?: Bood leukocyte subsets
How many people: 185 participants
Where: 1 siteBelarus
Study dates: 1 Jul 2021to 1 Jan 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 day to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Patients with severe viral infection, with sepsis on day 1 and day 7

Who may be able to join

age from 1 month to 18 years;
confirmed septic process$
informed consent.

Who cannot join

age from 18 years;
refuse of patient to participate in the trial;
chronic mental disorders with severe manifestations;
pregnancy/lactation;
intercurrent severe chronic diseases;
HIV, Hepatites B/C;

Show all 9Show fewer

active tuberculosis;
cachexia of any origin;
malignant neoplasms.

Trial locations and contacts

1 site in 1 country.

Belarus1 site

City Children's Infectious Clinical Hospital
Minsk

Other trials in Belarus

About this study

Official title: To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers

A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.).

Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.

Read the detailed description

analyze biochemical markers and immune status data in sepsis patients and in the comparison group;
assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients;
carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome);
assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process;
based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.

Conditions: Sepsis
Being tested: Bood leukocyte subsets
Keywords: Sepsis, monocytes, neutrophils, genetic polymorphism, PDRF
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bood leukocyte subsetsDiagnostic test
Also called assessment of genetic polymorphism
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils

Study groups in NCT05908162
Study group	Role	What they receive
Patients with sepsis on day 1		Patients with sepsis on day 1 Receives: Diagnostic Test: Bood leukocyte subsets
Patients with sepsis on day 7		Patients with sepsis on day 7 Receives: Diagnostic Test: Bood leukocyte subsets
Patients with severe bacterial infection		Patients with severe bacterial infection (pneumonia) Receives: Diagnostic Test: Bood leukocyte subsets
Patients with severe viral infection		Patients with severe viral infection (COVID19) Receives: Diagnostic Test: Bood leukocyte subsets

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes).
Leucocyte count was determined under a microscope in a Goryaev chamber.
Measured: 1 month
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)).
Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20211 Jan 2025

First posted18 Jun 2023
Study start1 Jul 2021
Primary completion25 Dec 2024
Study completion1 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05908162
Sponsor's protocol ID: RRPCEM_SEPSIS
Status last verified: Dec 2025
First submitted: 30 May 2023
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers
ClinicalTrials.gov ID: NCT05908162
Acronym / sponsor ID: RRPCEM_SEPSIS
Conditions: Sepsis
Keywords: Sepsis, monocytes, neutrophils, genetic polymorphism, PDRF
Study type: Observational
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
Collaborators: Belarusian State Medical University
Study start: 1 Jul 2021 (actual)
Primary completion: 25 Dec 2024 (actual)
Study completion: 1 Jan 2025 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 30 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.

Detailed description

analyze biochemical markers and immune status data in sepsis patients and in the comparison group;
assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients;
carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome);
assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process;
based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Patients with sepsis on day 1	–	Diagnostic Test: Bood leukocyte subsetsPatients with sepsis on day 1
Patients with sepsis on day 7	–	Diagnostic Test: Bood leukocyte subsetsPatients with sepsis on day 7
Patients with severe bacterial infection	–	Diagnostic Test: Bood leukocyte subsetsPatients with severe bacterial infection (pneumonia)
Patients with severe viral infection	–	Diagnostic Test: Bood leukocyte subsetsPatients with severe viral infection (COVID19)

Who may qualify

Ages: 1 day to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Patients with severe viral infection, with sepsis on day 1 and day 7

Key inclusion criteria (3 listed)

age from 1 month to 18 years;
confirmed septic process$
informed consent.

Key exclusion criteria (9 listed)

age from 18 years;
refuse of patient to participate in the trial;
chronic mental disorders with severe manifestations;
pregnancy/lactation;
intercurrent severe chronic diseases;

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 subsetsAlso: assessment of genetic polymorphismDetermination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils	Diagnostic test	Patients with sepsis on day 1, Patients with sepsis on day 7, Patients with severe bacterial infection, Patients with severe viral infection

Primary outcome

Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
Time frame: 1 month
Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes). Leucocyte count was determined under a microscope in a Goryaev chamber.
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
Time frame: 1 month
Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)). Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0.

Results and safety

Results posted to the registry on 30 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Sepsis on Day 1	50	50
Patients With Sepsis on Day 7	47	47
Patients With Severe Bacterial Infection	33	33
Patients With Severe Viral Infection	20	20
Control Group	35	35

Primary outcome: Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes

Time frame: 1 month. Mean (Inter-Quartile Range). Unit: 10^9 cells/l

Measure	Patients With Sepsis, Day 1 n = 50	Patients With Sepsis, Day 7 n = 47	Patients With Severe Bacterial Infection n = 33	Patients With Severe Viral Infection n = 20	Control Group n = 35
WBC, 10^9 cells/l	16.0 (8.7 to 19.8)	11.2 (7.7 to 18.6)	11.9 (8.7 to 14.3)	4.9 (3.8 to 7.1)	6.9 (6.0 to 8.8)
lymphocyte, 10^9 cells/l	1.83 (1.23 to 3.01)	3.10 (1.84 to 4.19)	1.93 (0.97 to 3.02)	1.14 (0.79 to 1.65)	3.24 (2.44 to 3.89)
T-lymphocytes,10^9 cells/l	1.28 (0.65 to 2.20)	2.0 (1.2 to 2.9)	1.24 (0.59 to 2.32)	0.81 (0.44 to 1.28)	2.1 (1.64 to 2.62)
NK-cells,10^9 cells/l	0.10 (0.05 to 0.19)	0.14 (0.08 to 0.35)	0.10 (0.06 to 0.22)	0.15 (0.09 to 0.21)	0.36 (0.23 to 0.50)
NKT-cells,10^9 cells/l	0.020 (0.012 to 0.044)	0.050 (0.026 to 0.11)	0.025 (0.012 to 0.041)	0.038 (0.022 to 0.071)	0.083 (0.041 to 0.16)
T-helpers,10^9 cells/l	0.65 (0.34 to 1.43)	1.0 (0.61 to 1.78)	0.73 (0.37 to 1.68)	0.40 (0.28 to 0.80)	1.19 (0.89 to 1.34)
T-cytotoxic,10^9 cells/l	0.40 (0.21 to 0.71)	0.69 (0.43 to 1.1)	0.39 (0.18 to 0.66)	0.30 (0.15 to 0.40)	0.74 (0.55 to 0.85)
B-lymphocytes,10^9 cells/l	0.36 (0.17 to 0.78)	0.54 (0.19 to 0.80)	0.58 (0.30 to 1.0)	0.16 (0.11 to 0.26)	0.43 (0.24 to 0.66)

Patients With Sepsis, Day 1 vs Patients With Severe Viral Infection vs Control Group: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)

Time frame: 1 month. Mean (Inter-Quartile Range). Unit: percentage of cells of parent population

Measure	Patients With Sepsis, Day 1 n = 50	Patients With Sepsis, Day 7 n = 47	Patients With Severe Bacterial Infection n = 33	Patients With Severe Viral Infection n = 20	Control Group n = 35
% leukocytes that are lymphocytes	15.2 (9.9 to 25.6)	30.3 (18.3 to 39.9)	15.7 (11.1 to 18.9)	24.9 (13.6 to 36.1)	44.5 (35.4 to 52.0)
% lymphocytes that are T-cells	67.4 (59.1 to 77.6)	71.5 (65.2 to 76.0)	62.9 (57.5 to 67.9)	69.3 (65.5 to 74.7)	71.5 (62.9 to 76.9)
% lymphocytes that are NK-cells	5.42 (3.01 to 10.98)	7.4 (4.3 to 10.2)	4.5 (3.2 to 10.7)	13.35 (8.79 to 18.32)	11.6 (8.0 to 17.1)
% T-lymphocytes that are NKT-cells	1.19 (0.6 to 2.3)	2.2 (1.0 to 3.5)	1.13 (0.7 to 2.1)	3.4 (1.85 to 5.45)	3.4 (1.5 to 4.2)
% T-lymphocytes that are T-helpers	37.6 (26.6 to 48.9)	41.4 (36.4 to 47.9)	36.8 (33.6 to 44.2)	39.8 (31.66 to 47.38)	34.8 (29.1 to 41.0)
% T-lymphocytes that are T-cytotoxic cells	20.1 (16.0 to 28.8)	24.8 (18.9 to 29.8)	19.1 (15.2 to 23.4)	22.46 (18.89 to 26.43)	22.9 (20.1 to 27.7)
% lymphocytes that are B-cells	20.5 (13.6 to 31.6)	17.3 (10.7 to 23.2)	27.4 (21.3 to 33.0)	14.18 (10.96 to 17.03)	13.5 (10.3 to 17.4)
% monocytes that are classical	74.6 (67.0 to 81.4)	81.2 (76.5 to 87.7)	83.0 (75.7 to 85.7)	78.0 (62.6 to 80.05)	82.8 (78.8 to 88.1)

Patients With Sepsis, Day 1 vs Patients With Severe Bacterial Infection vs Patients With Severe Viral Infection: p <0.05, Wilcoxon (Mann-Whitney)
Patients With Sepsis, Day 1 vs Patients With Severe Viral Infection vs Control Group: p <0.05, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Sepsis on Day 1	3 of 50 (6%)	0 of 50 (0%)	3 of 50
Patients With Sepsis on Day 7	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Patients With Severe Bacterial Infection	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Patients With Severe Viral Infection	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Control Group	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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. This study is not recruiting at the moment.

Elena G Fomina, Dr principal investigator

The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)

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, 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 9 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: finished, as of the sponsor's last update on 30 Dec 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?

Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908162.

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 30 Dec 2025.