Actively Recruiting
Geisinger Antibiotic Allergy Pilot Program: Assess and Address
Led by Geisinger Clinic · Updated on 2025-08-22
100
Participants Needed
3
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Geisinger Antibiotic Allergy Pilot Program: Assess and Address
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized male or female patients with a history of penicillin or penicillin-derivative allergy reported by patient or documented
- 18 years of age or older
- Patients who need treatment with penicillin, penicillin-derivative, or other beta-lactam antibiotics during hospital stay
- Able and willing to provide consent in English
You will not qualify if you...
- History of immediate severe allergic reaction or delayed hypersensitivity to penicillin or penicillin-derivative
- Hemodynamically unstable patients (e.g., oxygen saturation below 90%, respiratory rate 21 or more, severe hypoxia needing ventilation, low blood pressure needing support, heart rate over 100 beats per minute)
- Patients with uncontrolled lung diseases like asthma exacerbation or COPD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
2
Geisinger Community Medical Center
Scranton, Pennsylvania, United States, 18510
Actively Recruiting
3
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
Research Team
K
Karla Frank
CONTACT
T
Taesung Kwon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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