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Clinical Trials/NCT04392297
NCT04392297
Completed
Not Applicable

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

The Republican Research and Practical Center for Epidemiology and Microbiology1 site in 1 country45 target enrollmentJuly 1, 2019
ConditionsCMV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CMV
Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Enrollment
45
Locations
1
Primary Endpoint
Number of patients with thrombosis
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
January 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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