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Completed

NCT Number: NCT04392297

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

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.

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Key information

Conditions

CMV

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, 220114, Belarus

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bood leukocyte subsets

Diagnostic Test

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

CMV specific T-cells

Diagnostic Test

CMV specific T-cells detected by flow cytometry

serum CMV IgM / IgG antibodies

Diagnostic Test

serum CMV IgM / IgG antibodies detected by ELISA

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Collaborators

  • Belarusian State Medical University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 18, 2020
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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