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

Completed

• Conditions: CMV
• Interventions: Diagnostic Test: Bood leukocyte subsets; Diagnostic Test: CMV specific T-cells; Diagnostic Test: serum CMV IgM / IgG antibodies

• Registration Number: NCT04392297
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Brief 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• age 18 - 80 years;
• fever of not clear etiology
• confirmed CMV infection

Exclusion Criteria

• HIV infection
• taking hormones, cytostatics;
• drug addiction
• malignant neoplasms over the past 5 years.
• active viral hepatitis or liver cirrhosis;
• immunosuppressive conditions of any etiology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CMV infection	CMV specific T-cells	-
Patients with CMV infection	Bood leukocyte subsets	-
Patients with CMV infection	serum CMV IgM / IgG antibodies	-

Primary Outcome Measures

Name	Time	Method
Number of patients with thrombosis	1 month	Thrombosis as a complication of CMV infection and its association with immune status, CMV specific T-cells count and CMV specific antibodies level

Trial Locations

Locations (1)

The Republican Research and Practical Center for Epidemiology and Microbiology; 🇧🇾 Minsk, Belarus