Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
James Tarbox, MD
Summary
The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is: \- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge? Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.
Description
Anywhere from 5-15% of patients have a reported penicillin allergy listed in their medical record. However, most patients with this listed allergy had reactions with characteristics that would qualify their penicillin allergy as low-risk of having a subsequent serious reaction (when considering initial reaction symptoms, time since initial reaction and if treatment was required). Of patients with penicillin allergy listed, it has been demonstrated that \>90% can tolerate penicillin after further evaluation, indicating a significant number of patients with an unnecessary penicillin allergy labe…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Expresses interest in participating by calling or filling out information form on study website * Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate. Exclusion Criteria: * Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points) * History of acute kidney injury (acute interstitial nephritis), severe liver…
Interventions
- DrugAmoxicillin 250 MG
Liquid amoxicillin 250mg PO
- DrugPlacebo
Given prior to amoxicillin 250mg in one-dose group
- DrugAmoxicillin 62.5mg
Given first in two-dose group, liquid amoxicillin 62.5mg PO
- DrugAmoxicillin 187.5mg
Given second in two-dose group, liquid amoxicillin 187.5mg PO
Location
- Texas Tech University Health Sciences CenterLubbock, Texas