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

NCT ID: NCT04392297

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-01-31

Brief Summary

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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

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* 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.

Conditions

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CMV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CMV infection

Bood leukocyte subsets

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

CMV specific T-cells detected by flow cytometry

serum CMV IgM / IgG antibodies

Intervention Type DIAGNOSTIC_TEST

serum CMV IgM / IgG antibodies detected by ELISA

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

CMV specific T-cells

CMV specific T-cells detected by flow cytometry

Intervention Type DIAGNOSTIC_TEST

serum CMV IgM / IgG antibodies

serum CMV IgM / IgG antibodies detected by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Fomina, Dr

Role: PRINCIPAL_INVESTIGATOR

Head of the laboratory, RSPCEM

Locations

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The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_CMV

Identifier Type: -

Identifier Source: org_study_id

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