CMVNCT04392297
Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals
An observational study of CMV, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CMV
- What is being tested?
- Bood leukocyte subsets, CMV specific T-cells and serum CMV IgM / IgG antibodies
- How many people
- 45 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2019to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CMV infection
Who may be able to join
- age 18 - 80 years;
- fever of not clear etiology
- confirmed CMV infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site
The Republican Research and Practical Center for Epidemiology and Microbiology
Minsk, 220114
About this study
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
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.
- Conditions
- CMV
- Being tested
- Bood leukocyte subsets, CMV specific T-cells, serum CMV IgM / IgG antibodies
- Keywords
- Cytomegalovirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bood leukocyte subsetsDiagnostic 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
CMV specific T-cellsDiagnostic test
CMV specific T-cells detected by flow cytometry
serum CMV IgM / IgG antibodiesDiagnostic test
serum CMV IgM / IgG antibodies detected by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Patients with CMV infection | Not described Receives: Diagnostic Test: Bood leukocyte subsets; Diagnostic Test: CMV specific T-cells; Diagnostic Test: serum CMV IgM / IgG antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jul 2019
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Elena Fomina, Dr, Principal investigator, Head of the laboratory, RSPCEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392297
- Sponsor's protocol ID
- RRPCEM_CMV
- Status last verified
- Apr 2025
- First submitted
- 11 May 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04392297
- Acronym / sponsor ID
- RRPCEM_CMV
- Conditions
- CMV
- Keywords
- Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CMV infection | – | Diagnostic Test: Bood leukocyte subsets, Diagnostic Test: CMV specific T-cells, Diagnostic Test: serum CMV IgM / IgG antibodies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CMV infection
Key inclusion criteria (3 listed)
- age 18 - 80 years;
- fever of not clear etiology
- confirmed CMV infection
Key exclusion criteria (6 listed)
- HIV infection
- taking hormones, cytostatics;
- drug addiction
- malignant neoplasms over the past 5 years.
- active viral hepatitis or liver cirrhosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bood leukocyte subsetsDetermination 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 test | Patients with CMV infection |
| CMV specific T-cellsCMV specific T-cells detected by flow cytometry | Diagnostic test | Patients with CMV infection |
| serum CMV IgM / IgG antibodiesserum CMV IgM / IgG antibodies detected by ELISA | Diagnostic test | Patients with CMV infection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Fomina, Dr principal investigator
Head of the laboratory, RSPCEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with thrombosis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.