None listed
Conditions
Brief summary
Penicillin allergy labels are common and are associated with adverse outcomes. It is widely recommended that people with a penicillin allergy label have an assessment to check if they are truly allergic. However, access to penicillin allergy assessment services is currently very limited. This study will assesses the implementation of the ASCIA (Australian Society for Clinical Immunology and Allergy) 'Consensus statement for the assessment of patients with suspected penicillin allergies' in a real-world health care system. The study aims to identify children with a penicillin allergy label who are at no or low risk of a true penicillin allergy, arrange for them to undertake an assessment and de-label those with inappropriate penicillin allergies. The study aims to demonstrate that this model of care is safe, effective and is associated with health-economic benefits. It is hypothesised that children who are eligible for the study can be can be safely assessed and have have their allergy status verified in a community based private health service with no costs to the patient. It is hypothesised that the majority of patients will have their penicillin allergy label removed. Patients are assessed via the administration of a questionnaire and oral provocation challenge, if indicated. During an oral provocation challenge the patient takes a small and then larger amount of the antibiotic and observed to see if they react. If the patient does not have an immediate reaction they will complete a 5 days course of the antibiotic at home to assess for a delayed reactions. Patients are provided with documentation clearly stating their allergy status and which antibiotics can be safely taken. Parents and GPs are asked to update the My Health Record with their confirmed allergy status. Patients are followed-up for 12 months post intervention with a phone call at 4, 8 and 12 months.
Interventions
A patient with a penicillin allergy label will have a clinical assessment with a paediatrician to determine their risk of a true allergic reaction. The assessment will be completed via the administration of a questionnaire. The clinical assessment will be conducted via Telehealth or in person in the clinic rooms. It will take approximately 20 minutes. The assessment of risk and recommendations for ongoing management will be made in accordance with the Australian Society for Clinical Immunology a
A patient with a penicillin allergy label will have a clinical assessment with a paediatrician to determine their risk of a true allergic reaction. The assessment will be completed via the administration of a questionnaire. The clinical assessment will be conducted via Telehealth or in person in the clinic rooms. It will take approximately 20 minutes. The assessment of risk and recommendations for ongoing management will be made in accordance with the Australian Society for Clinical Immunology and Allergy (ASCIA) 'Consensus statement for the assessment of patients with suspected penicillin allergy'. Patients determined to be at no risk of a true allergic reaction will be "de-labelled" i.e. have their penicillin allergy label removed without further testing. Patients determined to be at low risk of a true penicillin allergy will be offered an oral provocation challenge in the emergency department. Patients determined to be at high risk of a true penicillin allergy will remain labelled as allergic. They will not be offered an oral provocation challenge and they will not be included in the outcome assessments described below. All patients will receive documentation (obtained from the Australian Society for Clinical Immunology and Allergy (ASCIA) website) verifying their allergy status (confirmed allergic or confirmed NOT allergic). Oral provocation challenges will be performed as a 2-stage oral provocation challenge in the emergency department. The antibiotic will be given as an oral suspension (liquid). The patient will be given 10% of the dose followed by the remaining 90% of the dose. In cases of unspecified ‘penicillin’ allergy the patient will be challenged against amoxicillin (a commonly used penicillin-antibiotic in the community). Doses for antibiotics: • Amoxicillin 15mg/kg (max 500mg) • Phenoxymethylpenicillin 10mg/kg (max 500mg) • Amoxicillin/clavulanic acid 22.5mg/kg (max 875 mg) • Flucloxacillin 12.5mg/kg (max 500mg) After receiving 10% of the dose, patients will be observed for 30 minutes for signs or symptoms of a reaction. If there are no signs or symptoms of a reaction then the remaining 90% of the dose should be given and the patient observed for a further 60 minutes. If the patient does not have an allergic reaction they will be given a 5 day course of the culprit/testing antibiotic to take home. This is to assess for delayed reactions. The patient receives 1 full dose in the emergency department. The 5 day course commences with the dose received in the emergency department. Doses for take home antibiotics: • Amoxicillin 15mg/kg twice daily (max 500mg) • Phenoxymethylpenicillin 10mg/kg twice daily (max 500mg) • Amoxicillin/clavulanic acid 22.5mg/kg twice daily (max 875 mg) • Flucloxacillin 12.5mg/kg twice daily (max 500mg) Take home antibiotics will be provided as oral suspensions (liquid) or a capsule if appropriate. Patients are asked to keep a diary to monitor adherence, side effects and reactions. Patients will also be called by the research nurse on approximately day 6-10. If the patient completes the 5 days course without having a delayed allergic reaction they will be "de-labelled" i.e. have their allergy label removed. After the patients allergy status has been confirmed they will be followed up for 12 months with telephone calls at 4, 8 and 12 months. A research team member will follow subjects to assess measurable clinical outcomes: utilisation of antibiotics in the community, type and cause of infections in the community, GP and other primary care provider visits, change in prescription patterns, presentation to ED, referrals and attendance at Immunology/Allergy clinic and details about hospital admissions.
Sponsors
Dr Amy Whittaker
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
• Parent reported allergy to penicillin • Age 1-16 years • Parent or legal guardian able to provide informed consent
Exclusion criteria
• History consistent with a ‘high risk’ of a penicillin allergy (rash within the last year, or angioedema and/or systemic symptoms or unknown history) • Pregnancy • Significant immunosuppression due to medical treatment including daily oral steroids exceeding a dose of 0.5mg/kg • Any unstable medical condition which in the opinion of the investigator will place them at increased risk should a serious adverse event occur e.g. poorly controlled asthma or heart failure
Outcome results
None listed