Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR).
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...
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ftnorthernterhls:oai:digitallibrary.health.nt.gov.au:10137/12252 2023-05-15T18:15:17+02:00 Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). James F Goh MSY Mouhtouris E Vogrin S Chua KYL Holmes NE Awad A Copaescu AM De Luca JF Zubrinich C Gin D Cleland H Douglas A Kern JS Katelaris CH Thien F Barnes S Yun J Tong W Smith WB Carr A Anderson T Legg A Bourke J Mackay LK Aung AK Phillips EJ Trubiano J 2022-08-17 e055906 https://hdl.handle.net/10137/12252 https://doi.org/10.1136/bmjopen-2021-055906 https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/35977774 eng eng England © 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. BMJ Open. 2022 Aug 17;12(8):e055906. doi:10.1136/bmjopen-2021-055906. 101552874 https://hdl.handle.net/10137/12252 BMJ open doi:10.1136/bmjopen-2021-055906 orcid:0000-0003-0469-5666 orcid:0000-0002-9183-5032 orcid:0000-0001-6541-5512 orcid:0000-0002-5111-6367 https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/35977774 12 Adolescent Adult Australia/epidemiology *Eosinophilia/complications Humans Leukocytes Mononuclear Prospective Studies Quality of Life Registries *Stevens-Johnson Syndrome/diagnosis/etiology/therapy Clinical Trial Protocol Journal Article 2022 ftnorthernterhls https://doi.org/10.1136/bmjopen-2021-055906 2022-10-23T13:02:23Z 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). Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia Fiona.JAMES@austin.org.au. Department of ... Article in Journal/Newspaper SCAR Northern Territory Government Health Library Services ePublications Austin New Zealand BMJ Open 12 8 e055906 |
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Open Polar |
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Northern Territory Government Health Library Services ePublications |
op_collection_id |
ftnorthernterhls |
language |
English |
topic |
Adolescent Adult Australia/epidemiology *Eosinophilia/complications Humans Leukocytes Mononuclear Prospective Studies Quality of Life Registries *Stevens-Johnson Syndrome/diagnosis/etiology/therapy |
spellingShingle |
Adolescent Adult Australia/epidemiology *Eosinophilia/complications Humans Leukocytes Mononuclear Prospective Studies Quality of Life Registries *Stevens-Johnson Syndrome/diagnosis/etiology/therapy James F Goh MSY Mouhtouris E Vogrin S Chua KYL Holmes NE Awad A Copaescu AM De Luca JF Zubrinich C Gin D Cleland H Douglas A Kern JS Katelaris CH Thien F Barnes S Yun J Tong W Smith WB Carr A Anderson T Legg A Bourke J Mackay LK Aung AK Phillips EJ Trubiano J Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
topic_facet |
Adolescent Adult Australia/epidemiology *Eosinophilia/complications Humans Leukocytes Mononuclear Prospective Studies Quality of Life Registries *Stevens-Johnson Syndrome/diagnosis/etiology/therapy |
description |
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). Centre for Antibiotic Allergy & Research, Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia Fiona.JAMES@austin.org.au. Department of ... |
format |
Article in Journal/Newspaper |
author |
James F Goh MSY Mouhtouris E Vogrin S Chua KYL Holmes NE Awad A Copaescu AM De Luca JF Zubrinich C Gin D Cleland H Douglas A Kern JS Katelaris CH Thien F Barnes S Yun J Tong W Smith WB Carr A Anderson T Legg A Bourke J Mackay LK Aung AK Phillips EJ Trubiano J |
author_facet |
James F Goh MSY Mouhtouris E Vogrin S Chua KYL Holmes NE Awad A Copaescu AM De Luca JF Zubrinich C Gin D Cleland H Douglas A Kern JS Katelaris CH Thien F Barnes S Yun J Tong W Smith WB Carr A Anderson T Legg A Bourke J Mackay LK Aung AK Phillips EJ Trubiano J |
author_sort |
James F |
title |
Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
title_short |
Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
title_full |
Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
title_fullStr |
Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
title_full_unstemmed |
Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR). |
title_sort |
study protocol: australasian registry of severe cutaneous adverse reactions (aus-scar). |
publisher |
England |
publishDate |
2022 |
url |
https://hdl.handle.net/10137/12252 https://doi.org/10.1136/bmjopen-2021-055906 https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/35977774 |
geographic |
Austin New Zealand |
geographic_facet |
Austin New Zealand |
genre |
SCAR |
genre_facet |
SCAR |
op_source |
12 |
op_relation |
© 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. BMJ Open. 2022 Aug 17;12(8):e055906. doi:10.1136/bmjopen-2021-055906. 101552874 https://hdl.handle.net/10137/12252 BMJ open doi:10.1136/bmjopen-2021-055906 orcid:0000-0003-0469-5666 orcid:0000-0002-9183-5032 orcid:0000-0001-6541-5512 orcid:0000-0002-5111-6367 https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/35977774 |
op_doi |
https://doi.org/10.1136/bmjopen-2021-055906 |
container_title |
BMJ Open |
container_volume |
12 |
container_issue |
8 |
container_start_page |
e055906 |
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1766188385236418560 |