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

NCT ID: NCT06823154

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eligible for study risk assessment questionnaire

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 Type: EXPERIMENTAL

Study questionnaire

Intervention Type: OTHER

In the first component of the study, research staff will survey patients for history pertinent to their BLA 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 OPC (eg, use of antihistamines within prior 72 hours).

Eligible for oral challenge in the emergency department

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.

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

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

Study questionnaire

Intervention Type: OTHER

In the first component of the study, research staff will survey patients for history pertinent to their BLA 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 OPC (eg, use of antihistamines within prior 72 hours).

Interventions

Amoxicillin

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

Intervention Type: DRUG

Study questionnaire

In the first component of the study, research staff will survey patients for history pertinent to their BLA 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 OPC (eg, use of antihistamines within prior 72 hours).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Michelle Science

Staff physician, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Monica Caldeira-Kulbakas

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000069700

Identifier Type: -

Identifier Source: org_study_id