Primary Care Amoxicillin Challenge

Oral Amoxicillin Challenge in the Primary Care Setting

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.

Study Overview

• Status: Withdrawn
• Conditions: Amoxicillin Allergy
• Intervention / Treatment: Drug: Amoxicillin

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients less than 18 years old who attend either of two hospital-affiliated general pediatric clinic sites who have an allergy to penicillin (or its derivatives) documented in their electronic medical record.

Exclusion Criteria:

• Patients who do not have an allergy to penicillin (or its derivatives) documented in their electronic medical record or patients with listed penicillin allergy whose parent/guardian declines to participate in the study. Patients will also be excluded if their penicillin allergy has been confirmed with either failed amoxicillin challenge or positive penicillin skin testing. Medically fragile children who cannot tolerate a direct oral challenge will be excluded but may be offered referral to allergy/immunology. If, on review of the history of the allergy, features of likely IgE mediated (onset in 1st hour of course or anaphylaxis requiring hospital care) or dangerous non-IgE mediated penicillin allergy (Stevens Johnson with penicillin, blistering rashes, penicillin related cytopenia) are obtained, these patients are also excluded from challenge but may be referred to allergy for further education and appropriate testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving one dose of amoxicillin.; Patients receiving one dose of amoxicillin and then observed for one hour for signs/symptoms off allergic reaction.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients reporting penicillin allergy	who are able to tolerate penicillin drug oral challenge in the primary care setting without prior referral to allergy/immunology.	12 months

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: STUDY00006018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes