Status:
COMPLETED
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge
Lead Sponsor:
Austin Health
Conditions:
Hypersensitivity, Immediate
Hypersensitivity, Delayed
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 delive...
Detailed Description
Patient-reported penicillin allergies result in poor health outcomes for patients and drive inappropriate antibiotic prescribing, antimicrobial resistance and healthcare costs. Our group has internall...
Eligibility Criteria
Inclusion
- Adult patients referred to the outpatient allergy clinic for a penicillin allergy history;
- Willing and able to give consent.
Exclusion
- 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 \[or steroid equivalent\]).
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT04454229
Start Date
July 1 2021
End Date
December 2 2022
Last Update
March 6 2023
Active Locations (6)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
3
Austin Health
Heidelberg, Victoria, Australia, 3084
4
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3000