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Streamlining antibiotic allergy testing for elective surgery patients using smartphone based apps

PeRiopErative Penicillin/Cephalosporin AlleRgy TEsting - A phase II feasibility/safety randomised control trial to empower anaesthetists to risk stratify and de-label antibiotic allergy labels in the perioperative period using digital health solutions.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001295932
Acronym
PREPARE
Enrollment
150
Registered
2020-11-30
Start date
2021-02-04
Completion date
2023-10-31
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Antibiotic adverse drug reactions (ADRs), commonly known as "allergies", are a major burden on patients and hospitals. Currently, up to one in four Australian and American patients admitted to hospital will report an antibiotic "allergy" (so-called antibiotic allergy “labels” [AAL]), many of which limit appropriate antibiotic usage. In many instances, patients may undergo challenge with the antibiotic due to incorrect allergy reporting and recording. The nature of a patient’s antibiotic allergy and what antibiotics should be avoided are a common source of confusion for both doctors and patients alike. Penicillin allergy labels in the perioperative space have been associated with inferior patient (e.g. increased rates of periprosthetic infection), hospital (e.g. increased surgical time), and prescribing outcomes (e.g. vancomycin > cefazolin utilization), and conversely in observational and non-controlled studies penicillin allergy “de-labelling” has been associated with improved utilization of beta-lactams and patient outcomes. Further, whilst direct oral penicillin challenge has increasing observational evidence for safety and efficacy, it has not been applied to the perioperative assessment of orthopaedic patients reporting a penicillin allergy. This project is a collaboration between Austin Health, Alfred Health and Royal Melbourne Hospital. The PREPARE study is a feasibility and safety randomized control trial examining feasibility and safety of enhanced antibiotic allergy assessment and penicillin allergy testing in the perioperative setting in surgical patients planned for elective surgery. The PREPARE study will examine the utility of decision support (via smartphone app) utilizing a validated Antibiotic Allergy Assessment Tool9 for patients reporting a penicillin allergy in the perioperative arena in identifying those patients appropriate for a direct oral penicillin challenge in the perioperative clinic. PREPARE hopes to provide a useful point of care toolkit to improve clinician antibiotic allergy knowledge, antibiotic prescribing and medication safety, subsequently benefiting patients, clinicians and hospital networks.

Interventions

Pre-operative risk stratification and de-labelling of antibiotic allergy labels: Aim: Develop and implement a point of care, smartphone app based beta-lactam allergy de-labelling tool in perioperative medicine and assess the safety and feasibility of this intervention. Materials: Risk stratification of antibiotic allergy labels via a custom built smartphone app, based on a validated assessment tool. To be used by anaesthetists during pre-operative assessment. Procedure: Participants in pre-op

Pre-operative risk stratification and de-labelling of antibiotic allergy labels: Aim: Develop and implement a point of care, smartphone app based beta-lactam allergy de-labelling tool in perioperative medicine and assess the safety and feasibility of this intervention. Materials: Risk stratification of antibiotic allergy labels via a custom built smartphone app, based on a validated assessment tool. To be used by anaesthetists during pre-operative assessment. Procedure: Participants in pre-operative assessment clinic (PAC) with penicillin or cephalosporin allergy will be randomised to either the intervention arm or control arm. Those randomised to intervention arm will go on to be risk-stratified. Risk stratification is carried out by clinical staff within the PAC during a routine 20min consultation via the use of a smartphone application containing the validated Antibiotic Allergy Assessment Tool. Pre-operative assessment occurs between 1 week and 1 day prior to surgery. Participants identified as having a 'low-risk' penicillin or cephalosporin allergy label will go on to be challenged with an oral dose of penicillin VK, amoxicillin or cefalexin and observed for 1 hour post. This challenge occurs on the same day, directly after risk stratification occurs. Delivered by who and where: Risk-stratification will be completed by anaesthetic specialist in pre-operative assessment outpatient clinic. Participants who go on to challenge will also be challenged with a dose of antibiotic and observed within the same outpatient clinic.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 18 years and above that are reviewed in the perioperative assessment clinic under the care of a surgerical unit, having a reported penicillin or cephalosporin allergy label, and will require intravenous antibiotic therapy in planned perioperative care.

Exclusion criteria

Inpatients Patients aged < 18 years Patients currently receiving beta-lactam antibiotic therapy Previous referral or assessment by a specialist for beta-lactam allergy Under the current care of an Allergy/Immunology specialist Require non-beta-lactam antibiotics for an infection or colonization with an organism resistant to beta-lactam (eg MRSA, ESBL producing gram negatives) Emergency or trauma surgery Contraindication for oral penicillin provocation • Patients receiving more than 10mg of prednisolone or equivalent daily • Patients receiving antihistamine therapies • Patients with a history of drug-associated anaphylaxis or idiopathic urticaria/anaphylaxis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026