Clinical trial NCT03659227: Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
Official title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stevens-Johnson Syndrome
Lyell Syndrome
Drug Reactions
AGEP
DRESS
Bullous Dermatosis Caused by Drug Treatment (Disorder)
Maculopapular Exanthem
Erythema Multiforme
Keywords: Drug reactions
severe cutaneous adverse reactions (SCARs
Stevens-Johnson syndrome
Lyell Syndrome
(generalized bullous) fixed drug reaction
AGEP
DRESS
drug induced IgA bullous dermatosis
maculopapular exanthema
erythema multiforme
sampling
collection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


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

Primary outcomes:
measure: Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
timeFrame: Day 0
Secondary outcomes:
measure: To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
timeFrame: Day 0
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor
Study officials:
affiliation: APHP
name: Saskia Oro, MD
role: PRINCIPAL_INVESTIGATOR
References: