Geisinger Antibiotic Allergy Pilot Program: Assess and Address

This is a prospective non-inferiority study to evaluate penicillin allergy history in patients with reported penicillin allergy, who require penicillin or penicillin-derivative antibiotic during inpatient admission using a focused questionnaire. A simplified scoring system will be assigned to patient responses, and the total score will be utilized to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative. Patients determined to have low risk based on this questionnaire will be offered a test dose (graded challenge) of amoxicillin in a supervised setting, and if they tolerate it, penicillin allergy label will be removed from patient's chart. We hypothesize that at least 95% of low-risk patients will successfully pass the graded amoxicillin challenge so the penicillin allergy label can be removed from their charts. A proportion as low as 0.85 would be a good clinical outcome and considered non-inferior to the expected proportion of 0.95.

NCT Number	NCT05464615
Lead Sponsor	Geisinger Clinic
Conditions	Penicillin Allergy
Enrollment	20 participants
Start Date	2024-03-04
Primary Completion	2026-01-20 (estimated)
Study Completion	2026-01-20 (estimated)
Updated on ClinicalTrials.gov	2026-07-20