NCT06823154

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

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	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).
OTHER	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).

Timeline

• Start date: 2023-11-27
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2025-02-12
• Last updated: 2025-11-26

Locations

1 site across 1 country: Canada