Geisinger Antibiotic Allergy Pilot Program: Assess and Address

Description

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.

Conditions

Penicillin Allergy

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Study Overview

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Study Details

Study overview

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.

Geisinger Antibiotic Allergy Pilot Program: Assess and Address (GAAP) Penicillin Allergy De-labeling in Inpatient Setting by Performing Direct Oral Amoxicillin Challenge in Low-risk Patients

Geisinger Antibiotic Allergy Pilot Program: Assess and Address

Condition
Penicillin Allergy
Intervention / Treatment

-

Contacts and Locations

Danville

Geisinger Medical Center, Danville, Pennsylvania, United States, 17822

Scranton

Geisinger Community Medical Center, Scranton, Pennsylvania, United States, 18510

Wilkes-Barre

Geisinger Wyoming Valley, Wilkes-Barre, Pennsylvania, United States, 18711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Geisinger Clinic,

Taesung Kwon, MD, PRINCIPAL_INVESTIGATOR, Geisinger Clinic

Study Record Dates

2025-12-31