Safely Preventing Errors and Complications due to Inappropriate Allergy Labelling: The SPECIAL Study - The Adult Arm.

Not Applicable

Recruiting

• Conditions: Antibiotic allergy; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12619000029190
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-11
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

Patients (male or female), 16 years and above, presenting as medical or surgical inpatients with a self-reported allergy to beta lactam and/or sulphonamide antibiotics. Clinical examination will determine whether the patient with a disease state, for example a chronic medical condition, is well enough to undergo allergy testing. Any acute condition that necessitated admission will be resolved before allergy testing.

Self-reported Antibiotic Allergy Label (AAL)
Allergy to any beta-lactam, or allergy to any beta lactam and/or an allergy to one of the following: sulphonamide, macrolide or quinolone antibiotic
Reported reaction to an intravenous or oral antibiotic
Age >16 years

Exclusion Criteria

Participants unable to give written informed consent
A history of severe cutaneous adverse reactions
Type II-IV reactions according to the ASCIA Criteria: Serum sickness, Stevens-Johnson Syndrome (SJS), Toxic epidermal necrolysis (TEN), Acute interstitial nephritis (AIN), Drug rash eosinophilia syndrome (DRESS), Acute Generalised Exanthematous Pustulosis (AGEP), haemolytic anaemia, Drug-induced liver injury (DILI).
Participants with clinically established intolerances or allergy to an antibiotic.
Females who are pregnant
Antihistamine intake within 2 days prior to the scheduled challenge (including medications whose primary use is not as antihistamine but which are known to interact with histamine receptors). Daily antihistamine intake required for management of chronic disease, e.g. chronic idiopathic urticaria.
Immunosuppressive treatment at the time of testing
Patients on beta-blocker medication
A relevant medical contraindication to testing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-month hospital readmission rate as assessed by data from hospital admission records. <br>[Six-months following antibiotic allergy testing to one year later.];Number of days spent in hospital (length of stay) as assessed by data from hospital admission records.[Six-months following antibiotic allergy testing to one year later.];Economic viability.<br><br>Assessed by costs associated with in-patient testing accessed from Hospital Finance Departments. <br>Assessed by costs associated with prescriptions for antibiotics, morbidity from infections, GP and pathology services. Sources will be PBS and Medicare Schedules.[Six-months following antibiotic allergy testing to one year later.]

Secondary Outcome Measures

Name	Time	Method
Antibiotic options available as assessed from patient records following clinical assessment and information given by participant during the follow-up phase of the study. [Assessed from the day of challenge, every three months up to one year after the testing date.<br>]