Allergy Amoxicillin, Beta-lactam Allergy Labels
Conditions
Keywords
Beta-lactam allergy labels, Pediatrics, Oral challenge, Emergency department
Brief 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.
Interventions
DRUGAmoxicillin
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).
OTHERStudy 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
The Hospital for Sick Children
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* All paediatric patients aged 1 month to 18 years who present to the SickKids ED with a reported BLA will be eligible for the allergy history component of the study.
Exclusion criteria
* Parent/guardian and/or patient unable to consent or assent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge. | Up to 2 weeks | In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a reported BLA who are low risk (potential impact) | Day 1 | 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). |
| The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks) | Up to 2 weeks | Successful BLA removal will be defined as tolerating OPC without any immediate adverse reaction. |
| The proportion of patients who receive or are prescribed amoxicillin or a first-generation cephalosporin, among patients who undergo OPC | Day 1 | — |
| Feasibility based on proportion of eligible participants who consent to OPC | Up to 2 weeks | — |
| Feasibility based on duration of allergy risk assessment and OPC (calculated using CRF timestamps) | Up to 2 weeks | — |
| Patient and caregiver perspectives on BLA and OPC | Day 1 | After completion of the oral challenge, participants and their caregivers will complete a study questionnaire to assess their opinions about the safety of the oral challenge and their comfortability with having the allergy label removed from their chart. |
Countries
Canada
Outcome results
None listed