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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142162
• Other study ID #: 02.18
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: Elena G Fomina, Dr
• Phone: +375173430417
• Email: feg1[@]tut.by
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current study evaluates the relationship between cell immunity, biochemical and genetic markers in patients with sepsis in order to develop algorithm for predicting the course and outcome of severe bacterial infections.

Description:

• To study the state of the immune system in patients with sepsis: the content of blood monocyte subpopulations (classical, intermediate and non-classical monocytes), HLA-DR expression on monocytes, CD64 expression on neutrophils, spontaneous and stimulated production of reactive oxygen species by blood neutrophils etc.;

• To study biochemical blood parameters and genetic polymorphism of immune response genes;

• To evaluate the relationship between genetic features of the patient's immune system, biochemical blood parameters, immune system cells and the severity of the pathological process.

• To develop an algorithm to prevent the development of sepsis in children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2); availability of written informed consent of the patient's legal representatives for the study.

Exclusion Criteria:

acute and chronic heart failure; renal failure; acute and chronic liver failure; acute and chronic leukemia, severe anemia; HIV infection; immunosuppressive therapy; malignant neoplasms

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• flow cytometry
Determination of monocytes subpopulations (classical monocytes (CD14++CD16-, intermediate monocytes (CD14++CD16+ and non-classical monocytes (CD14+/-CD16++) in the blood of patients, evaluation of the HLA-DR expression on monocytes, evaluation of CD64 expression on neutrophils
• ELISA
estimation of the TNF-a, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
• RFLP
assessment of polymorphism TNF-a, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes with restriction fragment length polymorphism technique

Locations

Country	Name	City	State
Belarus	Republican Research and Practical Centre for Epidemiology and Microbiology	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monocytes	proportion of classical monocytes (CD14++CD16-), intermediate monocytes (CD14++CD16+) and non-classical monocytes (CD14+/-CD16++); HLA-DR level of expression	3 years
Primary	neutrophils	percentage of CD64+ neutrophils and CD64 level of expression	3 years
Primary	cytokines levels in the serum	TNF-a, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum	3 years
Primary	genes polymorphism	TNF-a, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes polymorphism	3 years