Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

May 2, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France, 94010
        • Recruiting
        • Henri Mondor
        • Contact:
          • Saskia Oro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Time Frame: Day 0
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Time Frame: Day 0
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Saskia Oro, MD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2018

Primary Completion (Anticipated)

September 25, 2023

Study Completion (Anticipated)

September 25, 2028

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K180201J

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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