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

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Primary endpoint revised
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date changed from estimate of Apr 30, 2026 to Feb 17, 2026
    v3
  2. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Enrollment target: 191 to 500
    • Primary completion date: Dec 4, 2024 to Apr 30, 2026
    • Study completion date: Nov 27, 2025 to Dec 31, 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06823154
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)		 Allergy Amoxicillin, Beta-lactam Allergy Labels
Related terms Emergencies
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov