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临床试验/NCT03784482
NCT03784482已完成不适用

Multiple Drug Hypersensitivity Syndrome in a Large Database

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To measure retrospectively the frequency of MDH patients in our database.

研究概览

简要总结

Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking.

Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database.

Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To measure retrospectively the frequency of MDH patients in our database.

时间窗: 1 day

The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)

To measure retrospectively the frequency of MDH patients in our database

时间窗: 1 day

The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population

次要结局

  • To describe the MDH population, identify the most frequent associations of DHR(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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