Geisinger Antibiotic Allergy Pilot Program: Assess and Address

Conditions

• Penicillin Allergy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amoxicillin — DRUG
  We 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.

Study Details

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.

Key Dates

Start date

Mar 4, 2024

Status verified

Aug 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Amoxicillin Graded Challenge
  1. Obtain baseline vitals (heart rate, O2 saturation, blood pressure and respiratory rate). 2. Administer 0.7 ml (56 mg) of amoxicillin 400 mg/ 5ml orally followed by 30 minutes of observation for allergy symptoms and other adverse reactions (e.g., itching, hives, swelling, coughing, wheezing, throat tightness, difficulty breathing, abdominal pain, vomiting, lightheadedness, hypotension, low oxygen saturation, tachycardia) 3. If no allergy or adverse symptoms are noted, administer 2.5 ml (200 mg) of amoxicillin followed by 90 minutes of observation

Primary Outcome Measure

Success Rate of the Graded Amoxicillin Challenge [ Time Frame: The success rate will be determined at the completion within 1 year post implementation of the protocol. ]

Central Contacts

• Karla Frank
  570-214-4215
  [email protected]
• Taesung Kwon, MD
  [email protected]

Locations (3)

Find similar trials in Danville, PA

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