Actively Recruiting
Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
Led by James Tarbox, MD · Updated on 2025-05-01
380
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
J
James Tarbox, MD
Lead Sponsor
T
Texas Tech University Health Sciences Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Interested in participating by contacting the study or filling out a form on the study website
- Reports allergy to penicillin or related antibiotics (e.g., penicillin VK, amoxicillin, ampicillin, or unspecified penicillin allergy)
You will not qualify if you...
- Penicillin allergy classified as more than low-risk by PEN-FAST score of 3 or higher
- History of acute kidney injury, severe liver damage, serum sickness, or drug fever from penicillin
- Anaphylaxis for any reason in the past year
- Cognitive impairment preventing consent or collateral history
- Pregnant
- Any illness or condition increasing study participation risk as judged by clinician
- Active or history of acute angle closure glaucoma
- Use of H1 or H2 blockers within 72 hours before testing
- Currently receiving high-dose steroids or any antibiotics
- Use of beta blockers or ACE inhibitors requires discussion and joint decision with study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
J
Joshua A Peterson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here