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RECRUITING
NCT06303128
PHASE3

Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

Sponsor: James Tarbox, MD

View on ClinicalTrials.gov

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

Interventions

DRUG

Amoxicillin 250 MG

Liquid amoxicillin 250mg PO

DRUG

Placebo

Given prior to amoxicillin 250mg in one-dose group

DRUG

Amoxicillin 62.5mg

Given first in two-dose group, liquid amoxicillin 62.5mg PO

DRUG

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