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NCT Number: NCT06823154

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Allergy Amoxicillin Beta-lactam Allergy Labels Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Monica Caldeira-Kulbakas

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: Up to 2 weeks

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

Secondary outcomes

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

    Time frame: Day 1

    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).

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

    Time frame: Up to 2 weeks

    Successful BLA removal will be defined as tolerating OPC without any immediate adverse reaction.

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

    Time frame: Day 1

  4. Feasibility based on proportion of eligible participants who consent to OPC

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

  6. Patient and caregiver perspectives on BLA and OPC

    Time frame: Day 1

    After completion of the oral challenge, participants and their caregivers will complete a study questionnaire to assess their opinions about the safety of the oral challenge and their comfortability with having the allergy label removed from their chart.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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