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CompletedNCT04392297Updated Apr 6, 2025

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

An observational study in CMV, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • CMV

Keywords

  • Cytomegalovirus
03

In context

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with CMV infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • infection
  • taking hormones, cytostatics;
  • drug addiction
  • malignant neoplasms over the past 5 years.
  • active viral hepatitis or liver cirrhosis;
  • conditions of any etiology
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with CMV infection

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

Interventions

  • Diagnostic testBood 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

  • Diagnostic testCMV specific T-cells

    CMV specific T-cells detected by flow cytometry

  • Diagnostic testserum CMV IgM / IgG antibodies

    serum CMV IgM / IgG antibodies detected by ELISA

06

What researchers measure

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

    Time frame: 1 month

07

Study locations

1 site
  • The Republican Research and Practical Center for Epidemiology and Microbiology
    Minsk, 220114, Belarus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Jan 2025, 66 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2020
First posted
May 18, 2020
StartActual
Jul 1, 2019
Primary completionActual
Jan 31, 2025
CompletionActual
Jan 31, 2025
Last update
Apr 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04392297
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian State Medical University
Responsible party
Sponsor
First posted
May 18, 2020
Start date
Jul 1, 2019
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Apr 6, 2025

Study contacts

Elena Fomina, Dr
principal investigator · Head of the laboratory, RSPCEM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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