RT Journal Article
SR Electronic
T1 Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR)
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e055906
DO 10.1136/bmjopen-2021-055906
VO 12
IS 8
A1 Fiona James
A1 Michelle S Y Goh
A1 Effie Mouhtouris
A1 Sara Vogrin
A1 Kyra Y L Chua
A1 Natasha E Holmes
A1 Andrew Awad
A1 Ana-Maria Copaescu
A1 Joseph F De Luca
A1 Celia Zubrinich
A1 Douglas Gin
A1 Heather Cleland
A1 Abby Douglas
A1 Johannes S Kern
A1 Constance H Katelaris
A1 Francis Thien
A1 Sara Barnes
A1 James Yun
A1 Winnie Tong
A1 William B Smith
A1 Andrew Carr
A1 Tara Anderson
A1 Amy Legg
A1 Jack Bourke
A1 Laura K Mackay
A1 Ar Kar Aung
A1 Elizabeth J Phillips
A1 Jason Trubiano
YR 2022
UL http://bmjopen.bmj.com/content/12/8/e055906.abstract
AB Introduction Severe cutaneous adverse reactions (SCAR) are a group of T cell-mediated hypersensitivities associated with significant morbidity, mortality and hospital costs. Clinical phenotypes include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP). In this Australasian, multicentre, prospective registry, we plan to examine the clinical presentation, drug causality, genomic predictors, potential diagnostic approaches, treatments and long-term outcomes of SCAR in Australia and New Zealand.Methods and analysis Adult and adolescent patients with SCAR including SJS, TEN, DRESS, AGEP and another T cell-mediated hypersensitivity, generalised bullous fixed drug eruption, will be prospectively recruited. A waiver of consent has been granted for some sites to retrospectively include cases which result in early mortality. DNA will be collected for all prospective cases. Blood, blister fluid and skin biopsy sampling is optional and subject to patient consent and site capacity. To develop culprit drug identification and prevention, genomic testing will be performed to confirm human leukocyte antigen (HLA) type and ex vivo testing will be performed via interferon-γ release enzyme linked immunospot assay using collected peripheral blood mononuclear cells. The long-term outcomes of SCAR will be investigated with a 12-month quality of life survey and examination of prescribing and mortality data.Ethics and dissemination This study was reviewed and approved by the Austin Health Human Research Ethics Committee (HREC/50791/Austin-19). Results will be published in peer-reviewed journals and presented at relevant conferences.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12619000241134).