Single step oral provocation challenge in children with a low risk reported penicillin allergy (Safe-Step): a prospective study.

This prospective study will evaluate the outcomes of a single-dose oral provocation challenge in paediatric participants with a reported low-risk penicillin allergy. The one stage oral challenge will be undertaken as follows; the dose will be calculated in mg/kg according to the patient's weight and in accordance with the Australian Medicines Handbook paediatric dosage guidelines for the relevant penicillin. The dose will then be administered as either an oral tablet or an oral liquid, dependent on patient preference or dose dependent. In order to ensure adherence, these doses will be administered under direct supervision to ensure adherence. For the five-day extended course, the dose will be calculated as above and administered twice daily as observed by parents. and will be administered as either an oral tablet or an oral liquid, dependent of patient preference or dose dependent. There will be follow up via telephone on day 2 and say 7 of the five-day courses, to monitor adherence. As part of routine care, the study team will review patients at the Drug Allergy Clinic, gathering relevant data from their history, medical notes, and antibiotic allergy details. This includes the type and severity of the reaction, timing of the reaction, the interval between the dose administered and the reaction, any underlying illnesses or medications at the time of the reaction, route of administration, past and current medical history, family history of allergies or co-morbidities, and the management of both acute and post-reaction phases. This information will be included in the analysis. Eligible participants will be contacted by the study team—either during their initial consultation or via telephone call following the consultation—to invite them to participate in the study. Consented participants will then undergo a one-stage oral provocation challenge, where they will receive 100% of the calculated daily dose of penicillin based on their weight and age. Following the challenge, they will be observed for one hour in the hospital according to the Australian Society of Clinical Immunology and Allergy consensus guidelines. If no immediate reaction is observed, participants will then receive a five-day extended course of penicillin, which is the current standard clinical care. Upon discharge, parents will be provided with an updated, approved health information sheet, which includes detailed information on potential types of reactions, their management, and the proper steps to take if a reaction occurs. The sheet also contains contact information for families to reach out if they have concerns or notice any signs of a reaction. Additionally, an email address will be provided for families to share any relevant details or photos related to a reaction. Follow-up will take place on Day 2 and Day 7 after the initial challenge. The Day 2 phone call aims to establish contact with the family and ensure that the child is tolerating the extended treatment course without any issues. The Day 7 call is to confirm that the child has completed the course successfully and has not experienced any delayed reactions within the 48-hour post-treatment window. This allows us to update the Drug Allergy Notification, either removing the allergy label or confirming the allergy if a reaction has occurred.