Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Recruiting

• Conditions: Stevens-Johnson Syndrome; Drug Reactions; Maculopapular Exanthem; AGEP; DRESS; Bullous Dermatosis Caused by Drug Treatment (Disorder); Erythema Multiforme; Lyell Syndrome

• Registration Number: NCT03659227
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Study Start: 2018-09-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03
• Primary Completion: 2023-09-25
• Study Completion: 2028-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Henri Mondor; 🇫🇷 Créteil, France