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

Austin Health382 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

382

Conditions

Hypersensitivity, Immediate Hypersensitivity, Delayed Hypersensitivity Response

Interventions

Direct oral penicillin challengeOTHER

The patient will receive a single dose of oral penicillin, following baseline vital signs.

Standard of careOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients referred to the outpatient allergy clinic for a penicillin allergy history; 2. Willing and able to give consent. Exclusion Criteria: 1. Patient age is \< 18 years; 2. Patients with a PEN-FAST score less than 3 3. Pregnancy; 4. Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study; 5. 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; 6. Patients where the allergy history was not able to be confirmed with patient; 7. Patients on concurrent antihistamine therapy; 8. Patients receiving more than stress dose steroids (i.e. \> 50mg QID hydrocortisone \[or steroid equivalent\]).

Locations (6)

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

Outcomes

Primary Outcomes

The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)

Time frame: up to 48H after oral challenge

Secondary Outcomes

Proportion of patients referred to the outpatient allergy clinic that are eligible for intervention (i.e randomization) as per protocol [Eligibility to screened ratio]

Time frame: Before randomization

Feasibility of recruitment defined as the proportion of patients consenting to participate in the study as per protocol from eligible patients. [Recruitment to eligibility ratio].

Time frame: Before randomization

Feasibility of intervention delivery defined as the proportion of patients randomized to the intervention arm who had the intervention delivered as per protocol. [Intervention to recruitment ratio]

Time frame: Before randomization

The proportion of patients with a penicillin allergy who experience an antibiotic associated immune mediated adverse event OR severe adverse drug reaction as per protocol definitions.

Time frame: Up to 48h after the drug challenge

The proportion of patients with a penicillin allergy who experience an antibiotic associated non-immune mediated adverse event.

Time frame: Up to 48h after the drug challenge

The proportion of patients that will respect the protocol (protocol compliance)

Time frame: Up to 48h after the drug challenge

Proportion of patient with positive Penicillin Skin Testing

Time frame: Up to 48h after the drug challenge

Data from ClinicalTrials.gov

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