Penicillin De-labeling in the Pediatric Primary Care Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting
研究概览
简要总结
While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from ages 2-18 years with a history of parent-reported penicillin allergy.
排除标准
- •Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded
研究组 & 干预措施
Pediatric Patients with a history of penicillin allergy
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting
时间窗: Day 1
Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting
时间窗: Day 1
次要结局
- Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge(10-14 months after amoxicillin challenge)
研究者
Timothy Chow, MD
Assistant Professor
University of Texas Southwestern Medical Center
