Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
研究概览
简要总结
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.
Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.
Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.
These samples will be stored in a dedicated biological sampling department ("Platform of biological resources").
Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 y-old
- •Severe cutaneous drug reaction (AGEP, DRESS, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme
- •Signed consent
- •Social security affiliation
排除标准
- •Patients law protection
结局指标
主要结局
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
时间窗: Day 0
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
次要结局
- To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.(Day 0)