Program to assess and address penicillin allergies
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
This study is testing if people who think they are allergic to penicillin can safely take amoxicillin under supervision to see if they can stop being labeled as allergic.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geisinger Clinic Academic / other |
| Locations | 3 sites (Danville, Pennsylvania and 2 other locations) |
| Trial ID | NCT05464615 on ClinicalTrials.gov |
What this trial studies
This prospective non-inferiority study evaluates patients with reported penicillin allergies who require penicillin or its derivatives during hospitalization. Using a focused questionnaire, patients are scored to identify those at low risk for allergic reactions. Low-risk patients will undergo a supervised graded challenge with amoxicillin, and if tolerated, their penicillin allergy label will be removed. The study aims to demonstrate that at least 95% of these patients can safely receive amoxicillin without adverse reactions.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults with a reported history of penicillin allergy who require treatment with penicillin or its derivatives.
Not a fit: Patients with a history of severe allergic reactions to penicillin or those who are hemodynamically unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could safely remove unnecessary penicillin allergy labels from patients, allowing for more effective antibiotic treatment.
How similar studies have performed: Other studies have shown success with similar graded challenge approaches for penicillin allergies, indicating this method is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Danville, Pennsylvania and 2 other locations
- Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
- Geisinger Community Medical Center — Scranton, Pennsylvania, United States (Recruiting)
- Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Taesung Kwon, MD — Geisinger Clinic
- Study coordinator: Karla Frank
- Email: kfrank6@geisinger.edu
- Phone: 570-214-4215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.