Collection of samples and data for severe drug reactions
Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
This study is collecting samples and information from patients with severe skin reactions to better understand what causes these reactions and how to improve treatment and prevention.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT03659227 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical data and biological samples from patients experiencing severe cutaneous adverse reactions, such as Stevens-Johnson syndrome and Lyell syndrome. Conducted at the dermatology department of Henri Mondor Hospital in France, the study will involve collecting skin biopsies, blood samples, and other biological materials to enhance understanding of the immunological and genetic factors involved in these drug reactions. The collected data will support future research aimed at improving treatment and prevention strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced severe cutaneous drug reactions.
Not a fit: Patients under legal protection or those not experiencing severe drug reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of severe drug reactions, ultimately improving patient outcomes.
How similar studies have performed: While this approach is focused on observational data collection, similar studies have shown promise in understanding drug reactions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil
- Henri Mondor — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Saskia Oro, MD — Aphp
- Study coordinator: Saskia Oro, MD
- Email: saskia.oro@aphp.fr
- Phone: 0149812536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.