NCT04392297已完成不适用
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
The Republican Research and Practical Center for Epidemiology and Microbiology1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of patients with thrombosis
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 80 years;
- •fever of not clear etiology
- •confirmed CMV infection
排除标准
- •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
结局指标
主要结局
Number of patients with thrombosis
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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