- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392297
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
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Minsk, Belarus, 220114
- The Republican Research and Practical Center for Epidemiology and Microbiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Elena Fomina, Dr, Head of the laboratory, RSPCEM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRPCEM_CMV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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