ANZCTR - Registration

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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]

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

antibiotic allergy

Stevens-Johnson Syndrome

Toxic Epidermal Necrolysis

Drug Reaction with Eosinophilia and Systemic Symptoms

Acute Generalized Exanthematous Pustulosis

Condition category

Condition code

Inflammatory and Immune System

Allergies

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At one year post commencement of study

Secondary outcome [1]

Proportion (n, %) of SCAR treated with disease-modifying therapy
--Assessed via data-linkage to medical record

Timepoint [1]

At end of index patient admission

Secondary outcome [2]

Proportion (n, %) of SCAR referred for allergy assessment
--Assessed via data-linkage to medical record

Timepoint [2]

At one year patient follow up

Secondary outcome [3]

Proportion (n, %) of SCAR associated mortality
--Assessed via data-linkage to medical record

Timepoint [3]

Inpatient and 90-day

Secondary outcome [4]

Proportion (n, %) of SCAR associated with disease recurrence
--Assessed via data-linkage to medical record

Timepoint [4]

At one year follow up

Secondary outcome [5]

Risk factors associated with SCAR mortality
--Assessed via data-linkage to medical record

Timepoint [5]

90 day post index admission

Secondary outcome [6]

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]

12 months post SCAR onset

Secondary outcome [7]

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]

From bloods obtained at any time point from disease onset to 12 months post SCAR

Secondary outcome [8]

The long term sequalae of SCAR (QOL)
-Assessment via Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q)

Timepoint [8]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

The Alfred - Prahran

Recruitment hospital [3]

Campbelltown Hospital - Campbelltown

Recruitment hospital [4]

Box Hill Hospital - Box Hill

Recruitment hospital [5]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [6]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [7]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [8]

Nepean Hospital - Kingswood

Recruitment hospital [9]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [10]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [11]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [12]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [13]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [14]

Royal Hobart Hospital - Hobart

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3004 - Prahran

Recruitment postcode(s) [3]

2560 - Campbelltown

Recruitment postcode(s) [4]

3128 - Box Hill

Recruitment postcode(s) [5]

6150 - Murdoch

Recruitment postcode(s) [6]

3000 - Melbourne

Recruitment postcode(s) [7]

3168 - Clayton

Recruitment postcode(s) [8]

2747 - Kingswood

Recruitment postcode(s) [9]

6009 - Nedlands

Recruitment postcode(s) [10]

3065 - Fitzroy

Recruitment postcode(s) [11]

2010 - Darlinghurst

Recruitment postcode(s) [12]

5000 - Adelaide

Recruitment postcode(s) [13]

4029 - Herston

Recruitment postcode(s) [14]

7000 - Hobart

Funding & Sponsors

Funding source category [1]

University

Name [1]

Melbourne University

Address [1]

Department of Medicine (Austin Health)
Heidelberg
Victoria 3084

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Austin Hospital

Address [2]

145 Studley Road Heidelberg VIC 3084

Country [2]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Institute for Immunology and Infectious Diseases

Address [1]

Health Research Centre, Discovery Way, Murdoch WA 6150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee (HREC)

Ethics committee address [1]

145 Studley Road
Heidelberg
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/04/2019

Approval date [1]

20/05/2019

Ethics approval number [1]

Summary

Brief 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.

Trial website

www.ausscar.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jason Trubiano

Address

Austin Health
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 6676

Fax

+61 3 9496 6676

[email protected]

Contact person for public queries

Name

Jason Trubiano

Address

Austin Health
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 6676

Fax

+61 3 9496 6676

[email protected]

Contact person for scientific queries

Name

Jason Trubiano

Address

Austin Health
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 6676

Fax

+61 3 9496 6676

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4687	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

Source	Title	Year of Publication	DOI
Embase	The Role of In Vivo and Ex Vivo Diagnostic Tools in Severe Delayed Immune-Mediated Adverse Antibiotic Drug Reactions.	2021	https://dx.doi.org/10.1016/j.jaip.2020.12.052
Embase	Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR).	2022	https://dx.doi.org/10.1136/bmjopen-2021-055906

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically