Australian Registry of Severe Drug Reactions

Not Applicable

Recruiting

• Conditions: drug allergy; antibiotic allergy; Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; Drug Reaction with Eosinophilia and Systemic Symptoms; Acute Generalized Exanthematous Pustulosis; Inflammatory and Immune System - Allergies; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12619000241134
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of SCAR secondary to antibiotics (single primary outcome)<br>-Causal drugs obtained from data-linkage to medical records and assessment of primary causality by (i) site investigators and (ii) independent reviewers[At one year post commencement of study]