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The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department
Sponsor: The Hospital for Sick Children
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.
Official title: The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department: The De-Label Program Expansion
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2023-11-27
Completion Date
2026-12-31
Last Updated
2025-11-26
Healthy Volunteers
No
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).
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).
Locations (1)
Monica Caldeira-Kulbakas
Toronto, Ontario, Canada