Geisinger Antibiotic Allergy Pilot Program: Assess and Address
ConditionPenicillin Allergy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeisinger Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Sequential
Treatments tested in this trial
Amoxicillin
DrugWe will initially administer 1/5th (56 mg) of the goal dose of amoxicillin (256 mg) by oral route following the procedure outlined below. The total goal dose to be administered is amoxicillin 256 mg (3.2 ml of 400 mg/5 ml). These were numbers that came about for significance in relabeling penicillin allergies in patients in previous studies.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Amoxicillin Graded ChallengeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The success rate will be determined at the completion within 1 year post implementation of the protocol.Secondary outcomes
1
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.
Time frame
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 protocol2
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov