RecruitingEarly Phase 1

Geisinger Antibiotic Allergy Pilot Program: Assess and Address

United States100 participantsStarted 2024-03-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Hospitalized male or female patients with a history of Penicillin (PCN) allergy or PCN-derivative allergy as reported by patient or documented in Epic * ≥18 years of age * Patients with a medical need for treatment with a PCN or PCN-derivative or other beta-lactam antibiotics as determined by an inpatient provider * Able and willing to provide consent in English. Exclusion Criteria: * History of documented immediate-onset severe allergic reaction or delayed onset hypersensitivity reaction to a PCN or PCN-derivative * Patients who are hemodynamically unstable (e.g., pulse oximetry O2 saturation \<90 %, respiratory rate \>=21 per minute, severe hypoxia requiring non-invasive ventilation, high-flow nasal canula, or mechanical ventilation, refractory hypotension requiring vasopressor support, heart rate \>100 beats per minute, etc.) * Patients with uncontrolled pulmonary diseases (like exacerbation of asthma, Chronic Obstructive Pulmonary Disease (COPD), and/or other forms of chronic lung diseases)

What they're measuring

Success Rate of the Graded Amoxicillin Challenge

Timeframe: The success rate will be determined at the completion within 1 year post implementation of the protocol.

Trial details

NCT IDNCT05464615

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Karla Frank

570-214-4215 kfrank6@geisinger.edu