Collection of samples and data for severe drug reactions
Official title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Run by Assistance Publique - Hôpitaux de Paris · NCT03659227 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | September 26, 2018 |
| Main results expected | September 25, 2023 |
| Study ends | September 25, 2028 |
| Registry record updated | May 3, 2022 |
| Trial ID | NCT03659227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have experienced severe cutaneous drug reactions.
✕Probably not a fit
Patients under legal protection or those not experiencing severe drug reactions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is focused on observational data collection, similar studies have shown promise in understanding drug reactions, indicating potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mesenchymal stromal cell treatment for Lyell syndrome (SJS/TEN)
This will try intravenous adipose-derived mesenchymal stromal cells in adults with recent-onset Stevens–Johnson syndrome or toxic epidermal necrolysis to see if skin heals faster.
-
Diffusion MRI to map nerve lesions in obstetric brachial plexus palsy
This study tests diffusion MRI and tractography to better understand nerve injuries in people with obstetric brachial plexus palsy.
-
Long-term心理 and cognitive check after stem cell transplant for immune deficiencies
This study tests the long-term neurocognitive and psychological functioning of 6–8 year-old children who had an allogeneic stem cell transplant for a primary immune deficiency, at least two years after the transplant.
-
Benchmarking AI language models against tumor boards for oncology treatment decisions
This project tests whether frontier AI language models can match the treatment recommendations of multidisciplinary tumor boards for common cancers using standardized synthetic cases.
-
Gut microbes and autoinflammatory diseases: how they may be linked
This study tests whether gut bacteria and their byproducts relate to digestive and inflammatory symptoms in people with autoinflammatory diseases.
-
How Eye Dominance Affects Fusion in Healthy Adults
This study tests whether fusional vergence measurements differ when tested on the dominant eye versus the non-dominant eye in healthy adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.