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

NCT06823154 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

DRUG

Amoxicillin

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).

OTHER

Study questionnaire

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).

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2026-02-17
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823154 on ClinicalTrials.gov