PMID- 35977774
OWN - NLM
STAT- MEDLINE
DCOM- 20220819
LR  - 20220910
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 12
IP  - 8
DP  - 2022 Aug 17
TI  - Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions 
      (AUS-SCAR).
PG  - e055906
LID - 10.1136/bmjopen-2021-055906 [doi]
LID - e055906
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-gamma 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).
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - James, Fiona
AU  - James F
AUID- ORCID: 0000-0003-0469-5666
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia Fiona.JAMES@austin.org.au.
FAU - Goh, Michelle S Y
AU  - Goh MSY
AD  - Department of Dermatology, St Vincent's Hospital Melbourne Pty Ltd, Fitzroy, 
      Victoria, Australia.
AD  - Department of Dermatology, Alfred Health, Melbourne, Victoria, Australia.
FAU - Mouhtouris, Effie
AU  - Mouhtouris E
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
FAU - Vogrin, Sara
AU  - Vogrin S
AD  - Department of Medicine, The University of Melbourne, Melbourne, Victoria, 
      Australia.
FAU - Chua, Kyra Y L
AU  - Chua KYL
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
FAU - Holmes, Natasha E
AU  - Holmes NE
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
AD  - Department of Medicine, The University of Melbourne, Melbourne, Victoria, 
      Australia.
FAU - Awad, Andrew
AU  - Awad A
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
FAU - Copaescu, Ana-Maria
AU  - Copaescu AM
AUID- ORCID: 0000-0002-9183-5032
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
FAU - De Luca, Joseph F
AU  - De Luca JF
AUID- ORCID: 0000-0001-6541-5512
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
FAU - Zubrinich, Celia
AU  - Zubrinich C
AD  - Allergy, Asthma & Clinical Immunology, Alfred Health, Melbourne, Victoria, 
      Australia.
AD  - School of Public Health and Preventive Medicine, Monash University, Clayton, 
      Victoria, Australia.
FAU - Gin, Douglas
AU  - Gin D
AD  - Department of Dermatology, Alfred Hospital, Melbourne, Victoria, Australia.
FAU - Cleland, Heather
AU  - Cleland H
AD  - Victorian Adult Burns Service, Alfred Hospital, Melbourne, Victoria, Australia.
FAU - Douglas, Abby
AU  - Douglas A
AD  - Infectious Diseases and Infection Control, Peter MacCallum Cancer Centre, 
      Melbourne, Victoria, Australia.
FAU - Kern, Johannes S
AU  - Kern JS
AD  - Department of Medicine, The University of Melbourne, Melbourne, Victoria, 
      Australia.
AD  - Dermatology Department, The Royal Melbourne Hospital, Melbourne, Victoria, 
      Australia.
FAU - Katelaris, Constance H
AU  - Katelaris CH
AD  - Department of Immunology, Campbelltown Hospital, Campbelltown, New South Wales, 
      Australia.
FAU - Thien, Francis
AU  - Thien F
AD  - Eastern Health Clinical School, Monash University, Clayton, Victoria, Australia.
AD  - Department of Respiratory and Sleep Medicine, Eastern Health, Box Hill, Victoria, 
      Australia.
FAU - Barnes, Sara
AU  - Barnes S
AD  - Monash Lung Sleep Allergy and Immunology, Monash Health, Clayton, Victoria, 
      Australia.
FAU - Yun, James
AU  - Yun J
AD  - Immunology and Rheumatology, Nepean Hospital, Penrith, New South Wales, 
      Australia.
FAU - Tong, Winnie
AU  - Tong W
AD  - HIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, 
      Australia.
AD  - School of Clinical Medicine, St Vincent's Healthcare Clinical Campus, Faculty of 
      Medicine and Health, UNSW, Sydney, New South Wales, Australia.
FAU - Smith, William B
AU  - Smith WB
AD  - Clinical Immunology and Allergy, Royal Adelaide Hospital, Adelaide, South 
      Australia, Australia.
FAU - Carr, Andrew
AU  - Carr A
AD  - HIV & Immunology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, 
      Australia.
FAU - Anderson, Tara
AU  - Anderson T
AD  - Department of Infectious Diseases, Royal Hobart Hospital, Hobart, Tasmania, 
      Australia.
FAU - Legg, Amy
AU  - Legg A
AD  - Pharmacy Department, Royal Darwin Hospital, Casuarina, Northern Territory, 
      Australia.
FAU - Bourke, Jack
AU  - Bourke J
AD  - Department of Immunology, Fiona Stanley Hospital, Murdoch, Western Australia, 
      Australia.
FAU - Mackay, Laura K
AU  - Mackay LK
AD  - Department of Microbiology and Immunology, The University of Melbourne at The 
      Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, 
      Australia.
FAU - Aung, Ar Kar
AU  - Aung AK
AD  - Department of General Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
FAU - Phillips, Elizabeth J
AU  - Phillips EJ
AD  - Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, 
      Western Australia, Australia.
AD  - Departments of Medicine, Dermatology, Pathology, Microbiology, Immunology and 
      Pharmacology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
FAU - Trubiano, Jason
AU  - Trubiano J
AUID- ORCID: 0000-0002-5111-6367
AD  - Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, 
      Austin Health, Heidelberg, Victoria, Australia.
AD  - Department of Medicine, The University of Melbourne, Melbourne, Victoria, 
      Australia.
AD  - National Centre for Infections in Cancer, Peter MacCallum Cancer Centre, 
      Melbourne, Victoria, Australia.
LA  - eng
SI  - ANZCTR/ACTRN12619000241134
GR  - UM1 AI109565/AI/NIAID NIH HHS/United States
GR  - R01 HG010863/HG/NHGRI NIH HHS/United States
GR  - R01 AI152183/AI/NIAID NIH HHS/United States
GR  - R01 AI152183/MH/NIMH NIH HHS/United States
GR  - U01 AI154659/AI/NIAID NIH HHS/United States
GR  - R13 AR078623/AR/NIAMS NIH HHS/United States
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20220817
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Australia/epidemiology
MH  - *Eosinophilia/complications
MH  - Humans
MH  - Leukocytes, Mononuclear
MH  - Prospective Studies
MH  - Quality of Life
MH  - Registries
MH  - *Stevens-Johnson Syndrome/diagnosis/etiology/therapy
PMC - PMC9389100
OTO - NOTNLM
OT  - Adverse events
OT  - CLINICAL PHARMACOLOGY
OT  - Dermatological epidemiology
OT  - EPIDEMIOLOGY
OT  - IMMUNOLOGY
OT  - PREVENTIVE MEDICINE
COIS- Competing interests: None declared.
EDAT- 2022/08/18 06:00
MHDA- 2022/08/20 06:00
PMCR- 2022/08/17
CRDT- 2022/08/17 20:52
PHST- 2022/08/17 20:52 [entrez]
PHST- 2022/08/18 06:00 [pubmed]
PHST- 2022/08/20 06:00 [medline]
PHST- 2022/08/17 00:00 [pmc-release]
AID - bmjopen-2021-055906 [pii]
AID - 10.1136/bmjopen-2021-055906 [doi]
PST - epublish
SO  - BMJ Open. 2022 Aug 17;12(8):e055906. doi: 10.1136/bmjopen-2021-055906.