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临床试验/NCT06002802
NCT06002802已完成不适用

Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年3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
200
试验地点
1
主要终点
Complexity

研究概览

简要总结

This observational clinical study aims at the identification of novel biomarkers and causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious mononucleosis (IM).

Clinical, biochemical, and routine virological data were collected from 200 patients with IM, novel analytical tools were implemented, and immunological and virological experimental data were generated using blood samples and mouthwashes. Patients have been investigated within four weeks after the onset of symptoms as well as one month and six months thereafter.

详细描述

EBV-associated diseases are a severe and global health problem, and novel tools and targets for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly needed. Here we propose to use several novel experimental approaches to investigate immunological, virological, biochemical, and clinical features in an observational study on Munich IM patients.

This study aims at identifying biomarkers and causative factors of protracted and/or complicated IM to facilitate the development of novel approaches to early diagnosis, therapy, and prevention of severe, life-threatening, and chronic EBV-associated diseases, including post-viral syndromes.

Two hundred patients with IM onset within the last four weeks were recruited from Munich health care institutions and were re-investigated at one and six months after the onset of symptoms. A novel diagnostic scoring system was developed to indicate the severity, complexity, and protraction of symptoms.

Investigated clinical parameters, including reported symptoms and physical signs of IM, as well as candidate risk factors in the medical history of patients and family members. Peripheral blood was analysed by established and novel analytical assays to determine the immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.

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
0 Years 至 39 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • IM onset within the last four weeks
  • with at least one of four typical clinical findings (tonsillopharyngitis, fever, lymphadenopathy, fatigue) - virological findings indicating primary EBV infection (EBV-specific antibodies, EBV DNA).

排除标准

  • Pregnancy
  • transfusion
  • and/or transplantation during the last year
  • and/or no informed consent.

结局指标

主要结局

Complexity

时间窗: Six months

Maximal complexity of symptoms during the course of IM according the the IMMUC-Score

Protraction

时间窗: Six months

Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.

Severity

时间窗: Six months

Maximal severity of symptoms during the course of IM according the the IMMUC-Score.

次要结局

  • Immune status(Within four weeks post symptom onset and at one and six months thereafter.)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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