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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible for study risk assessment questionnaire | Experimental | First, a systematic allergy risk assessment tool will enable stratification of patients' reported symptoms as (1) low risk (eg, isolated urticarial, maculopapular rash, gastrointestinal symptoms) or (2) high risk (eg, anaphylaxis, severe systemic reactions). Only patients classified low risk will be eligible for oral provocation challenge for allergy delabeling. Patients' ineligible for oral provocation challenge because of history of high-risk allergy symptoms or presence of clinical confounders for oral provocation challenge (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation. |
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| Eligible for oral challenge in the emergency department | Experimental | A subset of patients screened with the risk assessment questionnaire will fulfill eligibility criteria to undergo the Oral provocation challenge. Specifically, these will be patients who (1) fulfill several procedural requirements (eg, parent able to observe child for 1 hour after oral provocation challenge), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the oral provocation challenge, and (3) meet other clinical criteria for oral provocation challenge (eg, vital signs within normal range). These participants will be given a one-time dose of Amoxicillin 17 mg/kg (maximum, 500 mg) and observed for 1 hour for a reaction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge. | In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a reported BLA who are low risk (potential impact) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monica Caldeira-Kulbakas | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Study questionnaire | Other | 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). |
|
| Day 1 |
| The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks) | Successful BLA removal will be defined as tolerating OPC without any immediate adverse reaction. | Up to 2 weeks |
| 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 | 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. | Day 1 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |