Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients law protection

Trial population

Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Time frame
Day 0

Secondary outcomes

1

To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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