The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department: The De-Label Program Expansion
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The primary outcome will be the proportion of patients delabeled among those given the OPC.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Parent/guardian and/or patient unable to consent or assent.
研究组 & 干预措施
Eligible for study risk assessment questionnaire
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.
干预措施: Study questionnaire (Other)
Eligible for oral challenge in the emergency department
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.
干预措施: Study questionnaire (Other)
Eligible for oral challenge in the emergency department
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.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
The primary outcome will be the proportion of patients delabeled among those given the OPC.
时间窗: Up to 2 weeks
In the primary analysis, successful BLA removal will be defined as tolerating OPC without any immediate adverse reaction.
次要结局
- The proportion of patients with a reported BLA who are low risk (potential impact)(Day 1)
- The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks)(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(Day 1)
研究者
Michelle Science
Staff physician, Principal Investigator
The Hospital for Sick Children