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Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
Sponsor: 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.
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2024-02-03
Completion Date
2026-12
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
Amoxicillin 250 MG
Liquid amoxicillin 250mg PO
Placebo
Given prior to amoxicillin 250mg in one-dose group
Amoxicillin 62.5mg
Given first in two-dose group, liquid amoxicillin 62.5mg PO
Amoxicillin 187.5mg
Given second in two-dose group, liquid amoxicillin 187.5mg PO
Locations (1)
Texas Tech University Health Sciences Center
Lubbock, Texas, United States