Trial Outcomes & Findings for Algorithm for Predicting the Unfavorable Course of Sepsis in Children (NCT NCT05908162)
NCT ID: NCT05908162
Last Updated: 2025-12-30
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
185 participants
Primary outcome timeframe
1 month
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Patients With Sepsis on Day 1
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Sepsis on Day 7
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Bacterial Infection
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Viral Infection
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Control Group
Group of healthy patients
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
47
|
33
|
20
|
35
|
|
Overall Study
COMPLETED
|
50
|
47
|
33
|
20
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Sepsis on Day 1
n=50 Participants
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Sepsis on Day 7
n=47 Participants
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Bacterial Infection
n=33 Participants
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Viral Infection
n=20 Participants
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Control Group
n=35 Participants
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=50 Participants
|
47 Participants
n=47 Participants
|
33 Participants
n=33 Participants
|
20 Participants
n=20 Participants
|
35 Participants
n=35 Participants
|
185 Participants
n=185 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=185 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=185 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=50 Participants
|
20 Participants
n=47 Participants
|
21 Participants
n=33 Participants
|
14 Participants
n=20 Participants
|
16 Participants
n=35 Participants
|
91 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=50 Participants
|
27 Participants
n=47 Participants
|
12 Participants
n=33 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=35 Participants
|
94 Participants
n=185 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belarus
|
50 participants
n=50 Participants
|
47 participants
n=47 Participants
|
33 participants
n=33 Participants
|
20 participants
n=20 Participants
|
35 participants
n=35 Participants
|
185 participants
n=185 Participants
|
PRIMARY outcome
Timeframe: 1 monthDetermination 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.
Outcome measures
| Measure |
Patients With Sepsis, Day 1
n=50 Participants
Patients with sepsis on day 1
|
Patients With Sepsis, Day 7
n=47 Participants
Patients with sepsis on day 7
|
Patients With Severe Bacterial Infection
n=33 Participants
Patients with severe bacterial infection (pneumonia)
|
Patients With Severe Viral Infection
n=20 Participants
Patients with severe viral infection (COVID19)
|
Control Group
n=35 Participants
Group of healthy patients
|
|---|---|---|---|---|---|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
Intermediate monocytes,10^9 cells/l
|
0.09 10^9 cells/l
Interval 0.025 to 0.2
|
0.04 10^9 cells/l
Interval 0.01 to 0.09
|
0.06 10^9 cells/l
Interval 0.03 to 0.13
|
0.05 10^9 cells/l
Interval 0.03 to 0.09
|
0.027 10^9 cells/l
Interval 0.018 to 0.043
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
WBC, 10^9 cells/l
|
16.0 10^9 cells/l
Interval 8.7 to 19.8
|
11.2 10^9 cells/l
Interval 7.7 to 18.6
|
11.9 10^9 cells/l
Interval 8.7 to 14.3
|
4.9 10^9 cells/l
Interval 3.8 to 7.1
|
6.9 10^9 cells/l
Interval 6.0 to 8.8
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
lymphocyte, 10^9 cells/l
|
1.83 10^9 cells/l
Interval 1.23 to 3.01
|
3.10 10^9 cells/l
Interval 1.84 to 4.19
|
1.93 10^9 cells/l
Interval 0.97 to 3.02
|
1.14 10^9 cells/l
Interval 0.79 to 1.65
|
3.24 10^9 cells/l
Interval 2.44 to 3.89
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
T-lymphocytes,10^9 cells/l
|
1.28 10^9 cells/l
Interval 0.65 to 2.2
|
2.0 10^9 cells/l
Interval 1.2 to 2.9
|
1.24 10^9 cells/l
Interval 0.59 to 2.32
|
0.81 10^9 cells/l
Interval 0.44 to 1.28
|
2.1 10^9 cells/l
Interval 1.64 to 2.62
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
NK-cells,10^9 cells/l
|
0.10 10^9 cells/l
Interval 0.05 to 0.19
|
0.14 10^9 cells/l
Interval 0.08 to 0.35
|
0.10 10^9 cells/l
Interval 0.06 to 0.22
|
0.15 10^9 cells/l
Interval 0.09 to 0.21
|
0.36 10^9 cells/l
Interval 0.23 to 0.5
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
NKT-cells,10^9 cells/l
|
0.020 10^9 cells/l
Interval 0.012 to 0.044
|
0.050 10^9 cells/l
Interval 0.026 to 0.11
|
0.025 10^9 cells/l
Interval 0.012 to 0.041
|
0.038 10^9 cells/l
Interval 0.022 to 0.071
|
0.083 10^9 cells/l
Interval 0.041 to 0.16
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
T-helpers,10^9 cells/l
|
0.65 10^9 cells/l
Interval 0.34 to 1.43
|
1.0 10^9 cells/l
Interval 0.61 to 1.78
|
0.73 10^9 cells/l
Interval 0.37 to 1.68
|
0.40 10^9 cells/l
Interval 0.28 to 0.8
|
1.19 10^9 cells/l
Interval 0.89 to 1.34
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
T-cytotoxic,10^9 cells/l
|
0.40 10^9 cells/l
Interval 0.21 to 0.71
|
0.69 10^9 cells/l
Interval 0.43 to 1.1
|
0.39 10^9 cells/l
Interval 0.18 to 0.66
|
0.30 10^9 cells/l
Interval 0.15 to 0.4
|
0.74 10^9 cells/l
Interval 0.55 to 0.85
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
B-lymphocytes,10^9 cells/l
|
0.36 10^9 cells/l
Interval 0.17 to 0.78
|
0.54 10^9 cells/l
Interval 0.19 to 0.8
|
0.58 10^9 cells/l
Interval 0.3 to 1.0
|
0.16 10^9 cells/l
Interval 0.11 to 0.26
|
0.43 10^9 cells/l
Interval 0.24 to 0.66
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
monocytes,10^9 cells/l
|
1.04 10^9 cells/l
Interval 0.35 to 1.55
|
0.78 10^9 cells/l
Interval 0.34 to 1.19
|
0.87 10^9 cells/l
Interval 0.55 to 1.5
|
0.4 10^9 cells/l
Interval 0.24 to 0.62
|
0.46 10^9 cells/l
Interval 0.35 to 0.5
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
сlassical monocytes,10^9 cells/l
|
0.66 10^9 cells/l
Interval 0.27 to 1.28
|
0.45 10^9 cells/l
Interval 0.14 to 0.93
|
0.76 10^9 cells/l
Interval 0.45 to 1.26
|
0.28 10^9 cells/l
Interval 0.19 to 0.51
|
0.38 10^9 cells/l
Interval 0.28 to 0.42
|
|
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
nonclassical monocytes,10^9 cells/l
|
0.014 10^9 cells/l
Interval 0.0022 to 0.038
|
0.008 10^9 cells/l
Interval 0.001 to 0.027
|
0.015 10^9 cells/l
Interval 0.0046 to 0.048
|
0.011 10^9 cells/l
Interval 0.007 to 0.021
|
0.004 10^9 cells/l
Interval 0.003 to 0.017
|
PRIMARY outcome
Timeframe: 1 monthDetermination 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.
Outcome measures
| Measure |
Patients With Sepsis, Day 1
n=50 Participants
Patients with sepsis on day 1
|
Patients With Sepsis, Day 7
n=47 Participants
Patients with sepsis on day 7
|
Patients With Severe Bacterial Infection
n=33 Participants
Patients with severe bacterial infection (pneumonia)
|
Patients With Severe Viral Infection
n=20 Participants
Patients with severe viral infection (COVID19)
|
Control Group
n=35 Participants
Group of healthy patients
|
|---|---|---|---|---|---|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% monocytes that are intermediate
|
11.4 percentage of cells of parent population
Interval 7.17 to 18.5
|
7.02 percentage of cells of parent population
Interval 3.42 to 9.7
|
6.28 percentage of cells of parent population
Interval 4.93 to 12.4
|
12.6 percentage of cells of parent population
Interval 7.83 to 19.65
|
6.1 percentage of cells of parent population
Interval 4.2 to 9.5
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% leukocytes that are lymphocytes
|
15.2 percentage of cells of parent population
Interval 9.9 to 25.6
|
30.3 percentage of cells of parent population
Interval 18.3 to 39.9
|
15.7 percentage of cells of parent population
Interval 11.1 to 18.9
|
24.9 percentage of cells of parent population
Interval 13.6 to 36.1
|
44.5 percentage of cells of parent population
Interval 35.4 to 52.0
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% lymphocytes that are T-cells
|
67.4 percentage of cells of parent population
Interval 59.1 to 77.6
|
71.5 percentage of cells of parent population
Interval 65.2 to 76.0
|
62.9 percentage of cells of parent population
Interval 57.5 to 67.9
|
69.3 percentage of cells of parent population
Interval 65.5 to 74.7
|
71.5 percentage of cells of parent population
Interval 62.9 to 76.9
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% lymphocytes that are NK-cells
|
5.42 percentage of cells of parent population
Interval 3.01 to 10.98
|
7.4 percentage of cells of parent population
Interval 4.3 to 10.2
|
4.5 percentage of cells of parent population
Interval 3.2 to 10.7
|
13.35 percentage of cells of parent population
Interval 8.79 to 18.32
|
11.6 percentage of cells of parent population
Interval 8.0 to 17.1
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% T-lymphocytes that are NKT-cells
|
1.19 percentage of cells of parent population
Interval 0.6 to 2.3
|
2.2 percentage of cells of parent population
Interval 1.0 to 3.5
|
1.13 percentage of cells of parent population
Interval 0.7 to 2.1
|
3.4 percentage of cells of parent population
Interval 1.85 to 5.45
|
3.4 percentage of cells of parent population
Interval 1.5 to 4.2
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% T-lymphocytes that are T-helpers
|
37.6 percentage of cells of parent population
Interval 26.6 to 48.9
|
41.4 percentage of cells of parent population
Interval 36.4 to 47.9
|
36.8 percentage of cells of parent population
Interval 33.6 to 44.2
|
39.8 percentage of cells of parent population
Interval 31.66 to 47.38
|
34.8 percentage of cells of parent population
Interval 29.1 to 41.0
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% T-lymphocytes that are T-cytotoxic cells
|
20.1 percentage of cells of parent population
Interval 16.0 to 28.8
|
24.8 percentage of cells of parent population
Interval 18.9 to 29.8
|
19.1 percentage of cells of parent population
Interval 15.2 to 23.4
|
22.46 percentage of cells of parent population
Interval 18.89 to 26.43
|
22.9 percentage of cells of parent population
Interval 20.1 to 27.7
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% lymphocytes that are B-cells
|
20.5 percentage of cells of parent population
Interval 13.6 to 31.6
|
17.3 percentage of cells of parent population
Interval 10.7 to 23.2
|
27.4 percentage of cells of parent population
Interval 21.3 to 33.0
|
14.18 percentage of cells of parent population
Interval 10.96 to 17.03
|
13.5 percentage of cells of parent population
Interval 10.3 to 17.4
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% monocytes that are classical
|
74.6 percentage of cells of parent population
Interval 67.0 to 81.4
|
81.2 percentage of cells of parent population
Interval 76.5 to 87.7
|
83.0 percentage of cells of parent population
Interval 75.7 to 85.7
|
78.0 percentage of cells of parent population
Interval 62.6 to 80.05
|
82.8 percentage of cells of parent population
Interval 78.8 to 88.1
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% monocytes that are nonclassical
|
2.03 percentage of cells of parent population
Interval 1.08 to 3.89
|
1.15 percentage of cells of parent population
Interval 0.56 to 2.43
|
2.16 percentage of cells of parent population
Interval 1.05 to 3.67
|
3.5 percentage of cells of parent population
Interval 1.39 to 5.3
|
1.1 percentage of cells of parent population
Interval 0.5 to 3.4
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% neutrophils that express CD64
|
83.9 percentage of cells of parent population
Interval 74.0 to 93.7
|
5.55 percentage of cells of parent population
Interval 1.25 to 33.9
|
81.4 percentage of cells of parent population
Interval 44.7 to 94.3
|
0.35 percentage of cells of parent population
Interval 0.2 to 16.33
|
0.7 percentage of cells of parent population
Interval 0.3 to 1.6
|
|
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
% monocytes that express HLA-DR
|
58.98 percentage of cells of parent population
Interval 28.76 to 96.64
|
88.54 percentage of cells of parent population
Interval 53.36 to 93.5
|
62.63 percentage of cells of parent population
Interval 44.07 to 95.6
|
86.4 percentage of cells of parent population
Interval 56.2 to 98.9
|
67.0 percentage of cells of parent population
Interval 56.3 to 97.1
|
Adverse Events
Patients With Sepsis on Day 1
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Patients With Sepsis on Day 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Severe Bacterial Infection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Severe Viral Infection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Sepsis on Day 1
n=50 participants at risk
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Sepsis on Day 7
n=47 participants at risk
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Bacterial Infection
n=33 participants at risk
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Patients With Severe Viral Infection
n=20 participants at risk
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
Control Group
n=35 participants at risk
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
|
|---|---|---|---|---|---|
|
Infections and infestations
death
|
6.0%
3/50 • 3 years
|
0.00%
0/47 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/20 • 3 years
|
0.00%
0/35 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Head of laboratory Fomina E.G.
Republican center of Hygiene, Epidemiology and Public Health
Phone: +375173740417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place