Allergy De-Labeling for Amoxicillin Allergy

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this trial?

Beta-lactams are the most common antibiotics prescribed to children, including penicillin and amoxicillin. They are usually more effective and have fewer side effects than other ty antibiotics. Some children can have reactions to these antibiotics that can be mistaken as an allergy, especially rashes that develop days to weeks later. In such cases, when children take the antibiotic again, they have no problem tolerating it; this is called "delabeling an allergy" with an "oral challenge". Based on our experience with a similar program among inpatients, we are implementing and evaluating an allergy delabeling program for children in the SickKids ED, with the hope and intent to delabel most children of their "allergies" using an oral challenge.

Eligibility Criteria

This trial is for children who have been labeled with an allergy to antibiotics like penicillin or amoxicillin, but might not truly be allergic. They should be visiting the emergency department and willing to undergo an 'oral challenge' to potentially remove the allergy label.

Inclusion Criteria

I am between 1 month and 18 years old and have a reported bee sting allergy.

Exclusion Criteria

I or my guardian cannot give consent.

Treatment Details

Interventions

• Allergy De-Labeling Program (Anti-biotic)

Trial Overview The study is testing a program where children in the emergency department are given a questionnaire and then take amoxicillin under supervision. The goal is to see if they can tolerate it without allergic reactions, effectively 'delabeling' their supposed allergy.

Participant Groups

Group I: Eligible for study risk assessment questionnaire Experimental Treatment 1 Intervention

First, a systematic allergy risk assessment tool will enable stratification of patients' reported symptoms as (1) low risk (eg, isolated urticarial, maculopapular rash, gastrointestinal symptoms) or (2) high risk (eg, anaphylaxis, severe systemic reactions). Only patients classified low risk will be eligible for OPC for allergy delabeling. Patients' ineligible for OPC because of history of high-risk allergy symptoms or presence of clinical confounders for OPC (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation.

Group II: Eligible for oral challenge in the emergency department Experimental Treatment 2 Interventions

A subset of patients screened with the risk assessment questionnaire will fulfill eligibility criteria to undergo the Oral provocation challenge. Specifically, these will be patients who (1) fulfill several procedural requirements (eg, parent able to observe child for 1 hour after OPC), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the OPC, and (3) meet other clinical criteria for OPC (eg, vital signs within normal range). These participants will be given a one-time dose of Amoxicillin 17 mg/kg (maximum, 500 mg) and observed for 1 hour for a reaction.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+