RecruitingNCT03659227

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

500 participants

Start Date

Sep 26, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria1

  • Patients law protection

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Locations(1)

Henri Mondor

Créteil, France

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NCT03659227


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