Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

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Toxic Epidermal Necrolysis
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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

December 2020