RecruitingACTRN12619000241134

Australian Registry of Severe Drug Reactions

Australian Registry of Severe Cutaneous Adverse drug Reactions

Sponsor

Austin Health

Enrollment

500 participants

Start Date

Jul 3, 2019

Study Type

Observational

Conditions

Drug Reaction with Eosinophilia and Systemic Symptoms Toxic Epidermal Necrolysis Stevens-Johnson Syndrome antibiotic allergy Acute Generalized Exanthematous Pustulosis drug allergy

Summary

The development of a national clinical and DNA registry, AUS-SCAR, of SCAR patients with severe T cell-mediated drug hypersensitivities will allow investigators to (i) perform surveillance for new and emerging drug causality, (ii) develop clinical prediction rules, (iii) understand best-practice treatment approaches, (iv) discover genomic predictors that prevent SCAR onset and (v) improve long-term outcomes and medication safety.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Severe cutaneous adverse reactions (SCARs) are rare but potentially life-threatening drug reactions that affect the skin. Conditions like Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), DRESS syndrome, and others can cause widespread skin damage, organ involvement, and in some cases death — often triggered by a medication that seemed safe. Identifying who is at risk and which drugs cause these reactions is extremely difficult without large, coordinated data collection. The Australian Registry of Severe Drug Reactions (AUS-SCAR) is a national clinical and genetic registry designed to collect data from patients who have experienced one of these serious reactions. By gathering clinical information and DNA samples from participants across multiple hospitals, researchers hope to identify genetic markers that predict susceptibility, understand which drugs are responsible, and improve long-term care for survivors. You may be eligible if you have been diagnosed by a specialist dermatologist or immunologist as having a confirmed SCAR reaction (such as DRESS, AGEP, SJS/TEN, or GBFDE) during a hospital admission at a participating site. You or your legal representative must be able to provide informed consent.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

National prospective observation study/registry of patients identified with a severe cutaneous adverse reaction (SCAR). Participants will be identified by site investigators as having SCAR. Identifie

National prospective observation study/registry of patients identified with a severe cutaneous adverse reaction (SCAR). Participants will be identified by site investigators as having SCAR. Identified patients meeting inclusion/exclusion criteria will be consented to one or more of - (i) access the medical record for clinical data, (ii) 12 month follow up questionnaire, (iii) saliva for DNA biobanking [single sample], (iv) blood test [single sample] for peripheral blood mononuclear cell (PBMC) storage, (v) skin biopsy of acute exanthema [applicable to only some sites for separate study - stub study with same researchers]. Patients followed until 12 months post SCAR onset.