NCT04392297

Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals

To Identify the Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals and to Develop Methods for the Diagnosis and Treatment of Patients in This Category

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Current study evaluates possible correlations between the content of various cell populations, the genetic material of the virus and antibodies to it in the blood of patients and the risk of thrombosis development in patients with acute CMV infection. А new method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent individuals and the treatment of patients in this category will be developed.

Detailed description

* evaluate the immune status main indicators that characterize the activation of immune system, immunosuppression and anergy (myeloid suppressor cells, T-regulatory cells, T-cells according to the stages of differentiation (naive - effector - memory), activated T-cells); * identify and characterize immunological disorders in patients with CMV infection complicated by thromboembolism of various localization; * determine the presence and quantitative content in plasma / serum and neutrophils of the CMV genetic material by real-time PCR; * study humoral immunity to CMV (IgM / IgG antibodies to CMV in serum); * determine the content of CMV specific T-cells in peripheral blood; * develop a method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent persons and treatment of patients in this category.

Conditions

• CMV

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bood leukocyte subsets	Determination of blood leukocyte subpopulations: myeloid suppressor cells, T-regulatory cells, T-cells according to the stages of differentiation (naive - effector - memory), activated T-cells; circulating endothelial cells
DIAGNOSTIC_TEST	CMV specific T-cells	CMV specific T-cells detected by flow cytometry
DIAGNOSTIC_TEST	serum CMV IgM / IgG antibodies	serum CMV IgM / IgG antibodies detected by ELISA

Timeline

• Start date: 2019-07-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2020-05-18
• Last updated: 2025-04-06

Locations

1 site across 1 country: Belarus