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Trial registered on ANZCTR


Registration number
ACTRN12619000241134
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
19/02/2019
Date last updated
10/09/2019
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Registry of Severe Drug Reactions
Scientific title
Australian Registry of Severe Cutaneous Adverse drug Reactions
Secondary ID [1] 297378 0
Nil known
Universal Trial Number (UTN)
U1111-1228-3995
Trial acronym
AUS-SCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
drug allergy 311521 0
antibiotic allergy 311522 0
Stevens-Johnson Syndrome 311523 0
Toxic Epidermal Necrolysis 311524 0
Drug Reaction with Eosinophilia and Systemic Symptoms 311525 0
Acute Generalized Exanthematous Pustulosis 311526 0
Condition category
Condition code
Inflammatory and Immune System 310162 310162 0 0
Allergies
Infection 310163 310163 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 313635 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319048 0
Proportion of SCAR secondary to antibiotics (single primary outcome)
-Causal drugs obtained from data-linkage to medical records and assessment of primary causality by (i) site investigators and (ii) independent reviewers
Timepoint [1] 319048 0
At one year post commencement of study
Secondary outcome [1] 366818 0
Proportion (n, %) of SCAR treated with disease-modifying therapy
--Assessed via data-linkage to medical record
Timepoint [1] 366818 0
At end of index patient admission
Secondary outcome [2] 366819 0
Proportion (n, %) of SCAR referred for allergy assessment
--Assessed via data-linkage to medical record
Timepoint [2] 366819 0
At one year patient follow up
Secondary outcome [3] 366820 0
Proportion (n, %) of SCAR associated mortality
--Assessed via data-linkage to medical record
Timepoint [3] 366820 0
Inpatient and 90-day
Secondary outcome [4] 366821 0
Proportion (n, %) of SCAR associated with disease recurrence
--Assessed via data-linkage to medical record
Timepoint [4] 366821 0
At one year follow up
Secondary outcome [5] 366822 0
Risk factors associated with SCAR mortality
--Assessed via data-linkage to medical record
Timepoint [5] 366822 0
90 day post index admission
Secondary outcome [6] 366823 0
Associations of variation within class I and/or II HLA in SCAR
--Via HLA typing of DNA samples obtained from original participant saliva samples
Timepoint [6] 366823 0
12 months post SCAR onset
Secondary outcome [7] 366824 0
Utility of in vitro/ex vivo diagnostics in assigning drug causality in SCAR
--Assessment via T-cell enzyme linked ImmunoSpot (ELISpot) assay
--Assessment via T-cell flow cytometry for T cell activation markers
--Assessment via other novel functional T cell assays
Timepoint [7] 366824 0
From bloods obtained at any time point from disease onset to 12 months post SCAR
Secondary outcome [8] 366825 0
The long term sequalae of SCAR (QOL)
-Assessment via Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q)
Timepoint [8] 366825 0
At 12 months follow up

Eligibility
Key inclusion criteria
1. Patient of participating hospital during acute SCAR episode
2. Ability to give informed consent or enabled representative (i.e. next of kin , medical power of attorney).
3. Identified by a specialist in the field of drug allergy as having a SCAR reaction, confirmed by two site investigators.
4. Dermatologist and/or immunologist confirmed phenotype or biopsy proven
5. Consistent with disease specific criteria outlined in protocol for: DRESS, AGEP, SJS/TEN, GBFDE
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to obtain informed consent
2. SCAR specific phenotype listed above that does not meet provided definitions
3. SCAR specific phenotype deemed not appropriate for inclusion as per site investigators
4. 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Where the data distribution conforms to a Gaussian distribution the mean will be compared using paired students t-tests. Where the data does not conform, the non-parametric Mann-Whitney U test will be used to assess differences. Chi square test or Fisher’s exact test will be used to assess differences in categorical data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
3/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 13097 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 13098 0
The Alfred - Prahran
Recruitment hospital [3] 13099 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 13100 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 13101 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 13102 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 13103 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 13104 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 13105 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 13106 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [11] 13107 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [12] 13108 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 13109 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [14] 13110 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 25606 0
3084 - Heidelberg
Recruitment postcode(s) [2] 25607 0
3004 - Prahran
Recruitment postcode(s) [3] 25608 0
2560 - Campbelltown
Recruitment postcode(s) [4] 25609 0
3128 - Box Hill
Recruitment postcode(s) [5] 25610 0
6150 - Murdoch
Recruitment postcode(s) [6] 25611 0
3000 - Melbourne
Recruitment postcode(s) [7] 25612 0
3168 - Clayton
Recruitment postcode(s) [8] 25613 0
2747 - Kingswood
Recruitment postcode(s) [9] 25614 0
6009 - Nedlands
Recruitment postcode(s) [10] 25615 0
3065 - Fitzroy
Recruitment postcode(s) [11] 25616 0
2010 - Darlinghurst
Recruitment postcode(s) [12] 25617 0
5000 - Adelaide
Recruitment postcode(s) [13] 25618 0
4029 - Herston
Recruitment postcode(s) [14] 25619 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 301947 0
University
Name [1] 301947 0
Melbourne University
Country [1] 301947 0
Australia
Funding source category [2] 301948 0
Hospital
Name [2] 301948 0
Austin Hospital
Country [2] 301948 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 301740 0
None
Name [1] 301740 0
Address [1] 301740 0
Country [1] 301740 0
Other collaborator category [1] 280544 0
Other Collaborative groups
Name [1] 280544 0
Institute for Immunology and Infectious Diseases
Address [1] 280544 0
Health Research Centre, Discovery Way, Murdoch WA 6150
Country [1] 280544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302628 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 302628 0
Ethics committee country [1] 302628 0
Australia
Date submitted for ethics approval [1] 302628 0
11/04/2019
Approval date [1] 302628 0
20/05/2019
Ethics approval number [1] 302628 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90874 0
Dr Jason Trubiano
Address 90874 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 90874 0
Australia
Phone 90874 0
+61 3 9496 6676
Fax 90874 0
+61 3 9496 6676
Email 90874 0
jason.trubiano@austin.org.au
Contact person for public queries
Name 90875 0
Jason Trubiano
Address 90875 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 90875 0
Australia
Phone 90875 0
+61 3 9496 6676
Fax 90875 0
+61 3 9496 6676
Email 90875 0
jason.trubiano@austin.org.au
Contact person for scientific queries
Name 90876 0
Jason Trubiano
Address 90876 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 90876 0
Australia
Phone 90876 0
+61 3 9496 6676
Fax 90876 0
+61 3 9496 6676
Email 90876 0
jason.trubiano@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to potentially sensitive nature of patient data this will not be publically presented


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    376954-(Uploaded-09-09-2019-09-32-49)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Role of In Vivo and Ex Vivo Diagnostic Tools in Severe Delayed Immune-Mediated Adverse Antibiotic Drug Reactions.2021https://dx.doi.org/10.1016/j.jaip.2020.12.052
EmbaseStudy protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR).2022https://dx.doi.org/10.1136/bmjopen-2021-055906
N.B. These documents automatically identified may not have been verified by the study sponsor.