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

NCT04392297 | Completed

• 1 other identifier: RRPCEM_CMV
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

CMV

Keywords

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

• Number of patients with thrombosis

  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

Study Arms (1)

Patients with CMV infection

Diagnostic Test: Bood leukocyte subsets; Diagnostic Test: CMV specific T-cells; Diagnostic Test: serum CMV IgM / IgG antibodies

Interventions

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

Patients with CMV infection

CMV specific T-cells DIAGNOSTIC_TEST

CMV specific T-cells detected by flow cytometry

Patients with CMV infection

serum CMV IgM / IgG antibodies DIAGNOSTIC_TEST

serum CMV IgM / IgG antibodies detected by ELISA

Patients with CMV infection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CMV infection

You may qualify if:

• age 18 - 80 years;
• fever of not clear etiology
• confirmed CMV infection

You may not qualify if:

• 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

Sponsors & Collaborators

• The Republican Research and Practical Center for Epidemiology and Microbiology: lead
• Belarusian State Medical University: collaborator

Study Sites (1)

The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, 220114, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Heparinized whole blood

Study Officials

• Elena Fomina, Dr

  Head of the laboratory, RSPCEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 18, 2020
• Study Start: July 1, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)