Penicillin Allergy Clinical Trial
— GAAPOfficial title:
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
Verified date | April 2024 |
Source | Geisinger Clinic |
Contact | Nicole Lee |
Phone | 570-214-1651 |
nrlee[@]geisinger.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 22, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Geisinger Community Medical Center | Scranton | Pennsylvania |
United States | Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Geisinger Clinic |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success Rate of the Graded Amoxicillin Challenge | Investigators have created a simplified scoring system, the questionnaire, to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative, so that patients with low risk will be offered a test dose (graded challenge) of amoxicillin to safely de-label penicillin allergy. If the questionnaire is designed appropriately for such a stratification process, no or at least minimal cases of post-challenge allergic reaction should be noted. | The success rate will be determined at the completion within 1 year post implementation of the protocol. | |
Secondary | Allergic reactions in low-risk patients | Investigators have created a simplified scoring system, the questionnaire, to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative, so that patients with low risk will be offered a test dose (graded challenge) of amoxicillin to safely de-label penicillin allergy. If the questionnaire is designed appropriately for such a stratification process, no or at least minimal cases of post-challenge allergic reaction should be noted. | Allergic reactions in low-risk patients Investigators will review and analyze the number and types of post-challenge allergic reaction in low risk patients within 1 year post implementation of the protocol | |
Secondary | Provider input on the GAAP Questionnaire to Identify Risk levels | A survey will be sent to the providers within the study who participated and provided the GAAP Questionnaire to identify participants who were appropriate for the graded amoxicillin challenge. | Surveys will be sent to participating providers 1-2 weeks post administration of the GAAP questionnaire.This process will be completed within 1 year post implementation of the protocol. |
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