NCT04454229

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

The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge - An International Multicenter Randomized Control Trial - The PALACE Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Austin Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 internally and externally validated a novel penicillin allergy clinician decision rule (PEN-FAST) that is able to identify low risk penicillin allergies with a negative predictive value of 96% (95%; 94-98%). Therefore, 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.

Conditions

• Hypersensitivity, Immediate
• Hypersensitivity, Delayed
• Hypersensitivity Response

Interventions

Type	Name	Description
OTHER	Direct oral penicillin challenge	The patient will receive a single dose of oral penicillin, following baseline vital signs.
OTHER	Standard of care	Routine management as per the treating clinicians that include skin prick and intradermal beta-lactam testing, followed by oral penicillin challenge in the setting of negative skin testing.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-02
• Completion: 2022-12-02
• First posted: 2020-07-01
• Last updated: 2023-03-06

Locations

6 sites across 3 countries: United States, Australia, Canada