Brief Title
Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
Official Title
Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Brief 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.
Study Type
Observational
Primary Outcome
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Secondary Outcome
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Condition
Stevens-Johnson Syndrome
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
500
Start Date
September 26, 2018
Completion Date
September 25, 2028
Primary Completion Date
September 25, 2023
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - Patients law protection
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Saskia Oro, MD, 0149812536, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03659227
Organization ID
K180201J
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Saskia Oro, MD, Principal Investigator, APHP
Verification Date
April 2022