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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-02

Brief Summary

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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.

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Detailed Description

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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

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Hypersensitivity, Immediate Hypersensitivity, Delayed Hypersensitivity Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Direct oral challenge in patients with PEN-Fast less than 3

Eligible patients referred to the outpatient clinic reporting a penicillin allergy will be identified and assessed with a standard clinical history and the calculation of the PEN-FAST score. PEN-FAST is a three-point clinical assessment tool recently externally validated in a multicenter study, with a PEN-FAST score of \< 3 associated with 96.7% negative predictive value.

Intervention:

The patient will receive a single dose of oral penicillin, following baseline vital signs (i.e. temperature, heart rate, blood pressure, respiratory rate, skin check).

Nursing staff will repeat vital signs as needed and after oral challenge while observing for signs of an immune mediated adverse reaction.

If at any stage an antibiotic associated adverse event is noted, standard of care treatment is offered by the attending clinicians (ex. adrenalin for immediate hypersensitivity reaction).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Direct oral antibiotic challenge

Direct oral antibiotic (penicillin) challenge in patients with PEN-Fast less than 3.

Group Type EXPERIMENTAL

Direct oral penicillin challenge

Intervention Type OTHER

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

Standard of care

Standard of care: skin testing and, if negative, oral challenge.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

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.

Interventions

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Direct oral penicillin challenge

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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 \[or steroid equivalent\]).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No