The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

Completed · Not applicable

Conditions studied: Hypersensitivity, Immediate, Hypersensitivity, Delayed, Hypersensitivity Response

In brief

Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

Key facts

Study ID

NCT04454229

Run by

Austin Health

People needed

382

Starts

2021-07-01

Expected to finish

2022-12-02

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients referred to the outpatient allergy clinic for a penicillin allergy history;
• Willing and able to give consent.

You may not qualify if…

• Patient age is < 18 years;
• Patients with a PEN-FAST score less than 3
• Pregnancy;
• Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study;
• Patients with history of type A adverse drug reaction, drug-associated anaphylaxis, idiopathic urticaria/anaphylaxis, mastocytosis, serum sickness, blistering skin eruption or acute interstitial nephritis;
• Patients where the allergy history was not able to be confirmed with patient;
• Patients on concurrent antihistamine therapy;
• Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone [or steroid equivalent]).

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Austin Health — Heidelberg, Victoria, Australia
• Peter MacCallum Cancer Center — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• McGill University Health Centre (MUHC) — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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