To evaluate the feasibility and safety of a novel strategy of performing direct amoxicillin-graded oral challenge (GOC) in a pediatric general practitioner office in a prospective pilot study.

Children aged 2 to 17 years old with emergency medical record-listed penicillin allergy labels were recruited from Children’s Health Medical Center of Dallas between December 2021 and October 2022.

Once eligibility was confirmed (excluding those with history of severe cutaneous adverse reaction phenotypes), patients underwent a 2-step nonblinded GOC with amoxicillin 50 mg followed by a 200 mg dose with a 10-minute interval in between doses and a 60-minute observation period performed during routine health care maintenance visits.

Eighty-six of the initial 112 (77%) screened were deemed eligible for participation. Twenty-three proceeded on to the challenge (21%). Of the 23 that underwent GOC, 21 passed without any reaction (91%). Of the 2 with reactions, 1 was an immediate erythematous macule, and the other patient had a delayed mild maculopapular exanthem that occurred approximately 4 hours after completion of the challenge. Both reactions were nonurticarial and improved with oral antihistamine therapy. All (100%) of the parents and caregivers reported satisfaction with the amoxicillin challenge testing, and all patients who completed the challenge without any reaction said they would use a penicillin antibiotic when prescribed by their physician.

This pilot study supports known data that most children who are labeled to have penicillin allergy are indeed not allergic when challenged, but also offers a novel process for completing in-office challenges by primary care physicians. Importantly, it supports evidence that direct GOC to amoxicillin is safe and parents and caregivers of those challenged are satisfied with the procedure and are likely to use penicillin antibiotics in the future if needed.

Primary care offices are often the first to encounter children who could benefit from antibiotic treatment, and thus are presented with challenges when patients are labeled as penicillin allergic. The investigators examined a unique approach to this problem that bears particular significance for pediatricians; performing amoxicillin challenges in their practice, a technique this study affirms as safe for the child and satisfactory for caregivers. This innovative approach also enhances efficiency by allowing for earlier delabeling of the child and reduces the utilization of more costly and potentially hazardous alternative antibiotics.