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

CMV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04392297
• Other study ID #: RRPCEM_CMV
• Status: Enrolling by invitation
• Start date: July 1, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CMV
• Cytomegalovirus Infections

Intervention

Diagnostic Test:
• 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
• CMV specific T-cells
CMV specific T-cells detected by flow cytometry
• serum CMV IgM / IgG antibodies
serum CMV IgM / IgG antibodies detected by ELISA

Locations

Country	Name	City	State
Belarus	The Republican Research and Practical Center for Epidemiology and Microbiology	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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