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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2021

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 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

Arms, Groups and Cohorts

  • Patients with CMV infection

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with thrombosis
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Republican Research and Practical Center for Epidemiology and Microbiology
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elena Fomina, Dr, Principal Investigator, Head of the laboratory, RSPCEM

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