An observational study in Sepsis, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed at 1 site in Belarus. Open to participants aged 1 Day to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 185 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →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.
Patients with severe viral infection, with sepsis on day 1 and day 7
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with sepsis on day 1
Diagnostic Test: Bood leukocyte subsets
Patients with sepsis on day 7
Diagnostic Test: Bood leukocyte subsets
Patients with severe bacterial infection (pneumonia)
Diagnostic Test: Bood leukocyte subsets
Patients with severe viral infection (COVID19)
Diagnostic Test: Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
Also known as: assessment of genetic polymorphism
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.
Time frame: 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.
Time frame: 1 month
| Milestone | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group |
|---|---|---|---|---|---|
| Started | 50 | 47 | 33 | 20 | 35 |
| Completed | 50 | 47 | 33 | 20 | 35 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| 10^9 cells/l | Patients With Sepsis, Day 1 | Patients With Sepsis, Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group |
|---|---|---|---|---|---|
| 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) |
| monocytes,10^9 cells/l | 1.04 (0.35 to 1.55) | 0.78 (0.34 to 1.19) | 0.87 (0.55 to 1.50) | 0.4 (0.24 to 0.62) | 0.46 (0.35 to 0.50) |
| сlassical monocytes,10^9 cells/l | 0.66 (0.27 to 1.28) | 0.45 (0.14 to 0.93) | 0.76 (0.45 to 1.26) | 0.28 (0.19 to 0.51) | 0.38 (0.28 to 0.42) |
| Intermediate monocytes,10^9 cells/l | 0.09 (0.025 to 0.20) | 0.04 (0.01 to 0.09) | 0.06 (0.03 to 0.13) | 0.05 (0.03 to 0.09) | 0.027 (0.018 to 0.043) |
| nonclassical monocytes,10^9 cells/l | 0.014 (0.0022 to 0.038) | 0.008 (0.001 to 0.027) | 0.015 (0.0046 to 0.048) | 0.011 (0.007 to 0.021) | 0.004 (0.003 to 0.017) |
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.
| percentage of cells of parent population | Patients With Sepsis, Day 1 | Patients With Sepsis, Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group |
|---|---|---|---|---|---|
| % 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) |
| % monocytes that are intermediate | 11.4 (7.17 to 18.5) | 7.02 (3.42 to 9.7) | 6.28 (4.93 to 12.4) | 12.6 (7.83 to 19.65) | 6.1 (4.2 to 9.5) |
| % monocytes that are nonclassical | 2.03 (1.08 to 3.89) | 1.15 (0.56 to 2.43) | 2.16 (1.05 to 3.67) | 3.5 (1.39 to 5.3) | 1.1 (0.5 to 3.4) |
| % neutrophils that express CD64 | 83.9 (74.0 to 93.7) | 5.55 (1.25 to 33.9) | 81.4 (44.7 to 94.3) | 0.35 (0.2 to 16.33) | 0.7 (0.3 to 1.6) |
| % monocytes that express HLA-DR | 58.98 (28.76 to 96.64) | 88.54 (53.36 to 93.5) | 62.63 (44.07 to 95.6) | 86.4 (56.2 to 98.9) | 67.0 (56.3 to 97.1) |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Sepsis on Day 1 | 3/50 (6%) | 3/50 (6%) | 0/50 (0%) |
| Patients With Sepsis on Day 7 | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Patients With Severe Bacterial Infection | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Patients With Severe Viral Infection | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Control Group | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Event | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group |
|---|---|---|---|---|---|
| deathInfections and infestations | 3/50 | — | — | — | — |
| Age, Categorical(Participants) | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group | Total |
|---|---|---|---|---|---|---|
| <=18 years | 50 | 47 | 33 | 20 | 35 | 185 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group | Total |
|---|---|---|---|---|---|---|
| Female | 20 | 20 | 21 | 14 | 16 | 91 |
| Male | 30 | 27 | 12 | 6 | 19 | 94 |
| Race and Ethnicity Not Collected(Participants) | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group | Total |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group | Total |
|---|---|---|---|---|---|---|
| Belarus | 50 | 47 | 33 | 20 | 35 | 185 |
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