NCT05165212

Primary Care Amoxicillin Challenge

Oral Amoxicillin Challenge in the Primary Care Setting

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. If the patient is able to tolerate oral amoxicillin, the antibiotic allergy in question will be removed from the patient's chart.

Detailed description

Patients with a documented allergy to amoxicillin, ampicillin, or penicillin who are deemed low-risk for true penicillin allergy based on history will be offered enrollment in the study. Patients will be scheduled for an oral amoxicillin challenge in the primary care office at a later date. During this challenge, patients will be given 10% of a weight-based dose of amoxicillin and then observed for 30 minutes for signs and symptoms of an allergic reaction. If no reaction occurs, they will be given the remaining 90% of the weight-based dose and observed for an additional 30 minutes. Emergency medications such as diphenhydramine and epinephrine will be immediately available if needed. If the patient completes oral amoxicillin challenge without a clinically significant reaction, penicillin (and/or amoxicillin/ampicillin) allergy will be removed from the patient's chart.

Conditions

• Amoxicillin Allergy

Interventions

Type	Name	Description
DRUG	Amoxicillin	Patients will be given 10% of a standard weight-based dose of amoxicillin and observed for signs/symptoms of allergic reaction for 30 minutes. If no reaction occurs, they will given the remaining 90% of the standard dose and observed for an additional 30 minutes.

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-12-31
• Completion: 2026-01-01
• First posted: 2021-12-21
• Last updated: 2023-10-18

Regulatory

• FDA-regulated drug study