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

Inclusion Criteria5

Patient of participating hospital during acute SCAR episode
Ability to give informed consent or enabled representative (i.e. next of kin , medical power of attorney).
Identified by a specialist in the field of drug allergy as having a SCAR reaction, confirmed by two site investigators.
Dermatologist and/or immunologist confirmed phenotype or biopsy proven
Consistent with disease specific criteria outlined in protocol for: DRESS, AGEP, SJS/TEN, GBFDE

Exclusion Criteria4

Unable to obtain informed consent
SCAR specific phenotype listed above that does not meet provided definitions
SCAR specific phenotype deemed not appropriate for inclusion as per site investigators
Alternative diagnosis for the clinical presentation – e.g. toxic shock syndrome, acute skin graft versus host disease, Kawasaki disease, pustular psoriasis, staphylococcal scalded skin syndrome, autoimmune bullous disease/ immunobullous disorder, autoimmune connective tissue disease

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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.