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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

November 27, 2023

Primary Completion Date

December 4, 2024

Study Completion Date

November 27, 2025

Conditions
Allergy AmoxicillinBeta-lactam Allergy Labels
Interventions
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)."

Trial Locations (1)

M5G1X8

Monica Caldeira-Kulbakas, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT06823154 - The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department | Biotech Hunter | Biotech Hunter