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临床试验/NCT03164044
NCT03164044Unknown不适用

Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy

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: 2017年1月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy

研究概览

简要总结

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs).

详细描述

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). Among commonly used CD63/CD203c markers, newly proposed molecules, such as CD69, CD107a, CD164, CD13, CD11b and CD300a will be assayed. Results obtained together with the other clinical data will be used to calculate sensitivity and specificity of the method.

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

入选标准

  • suspected allergy to antibiotics or NSAIDs in the last 1 year.

排除标准

  • autoimmune diseases;
  • hepatitis B/C;
  • other acute or chronic infectious diseases;
  • malignant neoplasms;
  • leukemia;
  • other severe acute or chronic intercurrent diseases;
  • pregnancy/lactation;
  • refuse of patient to participate in the trial.

结局指标

主要结局

Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy

时间窗: 1 month

Sensitivity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs

Specificity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy

时间窗: 1 month

Specificity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs

次要结局

未报告次要终点

研究者

发起方
The Republican Research and Practical Center for Epidemiology and Microbiology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrei Y. Hancharou

Head of the Laboratory for Immunology and Cellular Biotechnology

The Republican Research and Practical Center for Epidemiology and Microbiology

研究点 (1)

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