The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department

NCT06823154 | Active Not Recruiting Phase 1

• 1 other identifier: 1000069700
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergy Amoxicillin; Beta-lactam Allergy Labels

Keywords

Beta-lactam allergy labels; Pediatrics; Oral challenge; Emergency department

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge.

  In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction.

  Up to 2 weeks

Secondary Outcomes (6)

• The proportion of patients with a reported BLA who are low risk (potential impact)

  Day 1

• The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks)

  Up to 2 weeks

• The proportion of patients who receive or are prescribed amoxicillin or a first-generation cephalosporin, among patients who undergo OPC

  Day 1

• Feasibility based on proportion of eligible participants who consent to OPC

  Up to 2 weeks

• Feasibility based on duration of allergy risk assessment and OPC (calculated using CRF timestamps)

  Up to 2 weeks

Study Arms (2)

Eligible for study risk assessment questionnaire

EXPERIMENTAL

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 oral provocation challenge for allergy delabeling. Patients' ineligible for oral provocation challenge because of history of high-risk allergy symptoms or presence of clinical confounders for oral provocation challenge (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation.

Other: Study questionnaire

Eligible for oral challenge in the emergency department

EXPERIMENTAL

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 oral provocation challenge), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the oral provocation challenge, and (3) meet other clinical criteria for oral provocation challenge (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.

Drug: Amoxicillin; Other: Study questionnaire

Interventions

Amoxicillin DRUG

Prospective cohort study of patients presenting to the emergency department with a reported beta-lactam allergy. (1) Allergy history and risk assessment, (2) Oral provocation challenge (if eligible), and (3) Post-discharge follow-up (if received oral provocation challenge or referred to allergy).

Eligible for oral challenge in the emergency department

Study questionnaire OTHER

In the first component of the study, research staff will survey patients for history pertinent to their beta-lactam allergy label. This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components. Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the oral provocation challenge (eg, use of antihistamines within prior 72 hours).

Eligible for oral challenge in the emergency department; Eligible for study risk assessment questionnaire

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All paediatric patients aged 1 month to 18 years who present to the SickKids ED with a reported BLA will be eligible for the allergy history component of the study.

You may not qualify if:

• Parent/guardian and/or patient unable to consent or assent.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Monica Caldeira-Kulbakas

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Emergencies

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician, Principal Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: February 12, 2025
• Study Start: November 27, 2023
• Primary Completion: February 17, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)