Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03659227

Enrollment

500

Registered

2018-09-06

Start date

2018-09-26

Completion date

2028-09-25

Last updated

2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

* Patients law protection

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Contacts

Primary ContactSaskia Oro, MD

saskia.oro@aphp.fr0149812536

Backup ContactLaetitia Gregoire

laetitia.gregoire@aphp.fr0149814164

Outcome results