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临床试验/NCT03702283
NCT03702283已完成不适用

Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Penicillin Allergy Label Removal

研究概览

简要总结

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the ICU setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as NCT03702270)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • VUMC patients age 18 or older with a penicillin allergy reported in their chart and are medically stable, currently admitted to ICU.

排除标准

  • Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.

结局指标

主要结局

Penicillin Allergy Label Removal

时间窗: Hospital discharge at approximately 7 days after ICU transfer

The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge

时间窗: Hospital discharge at approximately 7 days after ICU transfer

The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge

次要结局

  • Communication About Penicillin Allergy in Discharge Summary(Hospital discharge at approximately 7 days after ICU transfer)
  • Adverse Events (in Particular, Reported Allergic Events)(Hospital discharge at approximately 7 days after ICU transfer)
  • Antibiotic Utilization by Patients(2 years observation)

研究者

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

Elizabeth J Phillips

Professor

Vanderbilt University Medical Center

研究点 (2)

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