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临床试验/NCT04060550
NCT04060550Unknown不适用

Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients

National Jewish Health1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
Monocytes surface bound IgE quantities

研究概览

简要总结

This study investigates whether blood monocytes' surface bound- immunoglobulin E affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.

详细描述

Some of atopic dermatitis patients (AD) have severe herpes simplex viral (HSV) infections, which could cause erosive skin lesions all over the body. This condition is termed as eczema herpeticum (ADEH+). Scientists have found that ADEH+ patients have significantly increased blood immunoglobulin (Ig) E compared to AD patients without eczema herpeticum and healthy people. Increased IgE in blood could bound to immune cells' surface, such as monocytes. Since monocytes serve as the first line defense to fight viral infection, their surface-bound IgE may interfere their anti-viral immune responses, and consequently results in more severe viral infections. The purpose of this study is to learn more about how increased IgE affect body's immune ability to fight herpes simplex viruses. This study includes three groups: AD patient without eczema herpeticum complication(ADEH-); AD patient with eczema herpeticum complication(ADEH+) and healthy controls. Study results will be compared between groups.

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
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16-65 years old, age, sex and race match among non-atopic, ADEH- and ADEH+.
  • Participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions:
  • A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
  • A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.
  • Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.

排除标准

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Known or suspected immunosuppression
  • Severe concomitant illness(es)
  • Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  • Use of any other investigational agent in the last 30 days

结局指标

主要结局

Monocytes surface bound IgE quantities

时间窗: One day

Relative quantities of surface bound IgE

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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