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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04392297

Enrollment

Registered

2020-05-18

Start date

2019-07-01

Completion date

2025-01-31

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV

Keywords

Cytomegalovirus

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.

Interventions

DIAGNOSTIC_TESTBood 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_TESTCMV specific T-cells

CMV specific T-cells detected by flow cytometry

DIAGNOSTIC_TESTserum CMV IgM / IgG antibodies

serum CMV IgM / IgG antibodies detected by ELISA

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026