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

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Minsk, Belarus, 220114
        • The Republican Research and Practical Center for Epidemiology and Microbiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with CMV infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CMV infection
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 detected by flow cytometry
serum CMV IgM / IgG antibodies detected by ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elena Fomina, Dr, Head of the laboratory, RSPCEM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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