Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT03659227

Collaborator

(none)

500

Enrollment

Location

120

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stevens-Johnson Syndrome Lyell Syndrome Drug Reactions AGEP DRESS Bullous Dermatosis Caused by Drug Treatment (Disorder) Maculopapular Exanthem Erythema Multiforme

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Actual Study Start Date :

Sep 26, 2018

Anticipated Primary Completion Date :

Sep 25, 2023

Anticipated Study Completion Date :

Sep 25, 2028

Outcome Measures

Primary Outcome Measures

Implementation of a clinical data and biological samples collection for cutaneous adverse reactions [Day 0]
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Secondary Outcome Measures

To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions. [Day 0]
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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