NCT02031120终止不适用
Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic
研究概览
简要总结
The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake.
排除标准
- •Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).
结局指标
主要结局
Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic
时间窗: 3 years
次要结局
- Evaluation of the diagnostic values of the different allergy tests available(3 years)
- Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later(3 years)
研究者
Jean-Christoph Caubet
Chef de clinique
University Hospital, Geneva
研究点 (1)
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