Primary Care Amoxicillin Challenge

NCT05165212 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00006018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Amoxicillin Allergy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients receiving one dose of amoxicillin.

EXPERIMENTAL

Patients receiving one dose of amoxicillin and then observed for one hour for signs/symptoms off allergic reaction.

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

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.

Patients receiving one dose of amoxicillin.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 21, 2021
• Study Start: December 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share