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临床试验/NCT05010304
NCT05010304已完成4 期

Penicillin De-labeling in the Pediatric Primary Care Setting

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年12月9日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy Chow, MD

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (1)

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