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临床试验/NCT05090527
NCT05090527已完成不适用

Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge

研究概览

简要总结

A investigational study to establish:

  1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.

  2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.

  3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.

  4. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.

详细描述

Patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, To be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale.

One of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i Norwegian, the lack of in vitro tests for severe late /T cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test.

In this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. The low risk patient will then directly undergo a single full dose amoxicillin challenge. High risk patients are refered to a allergologic clinic and undergoes full allergologic examination. The investigators seek to document that in low risk patients is a single dose Amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in Norwegian.

To implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. Here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned.

Finally we will implement the method in an implementation study across the Western Norway Health region

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

盲法说明

None, open provocation test with amoxicillin for eligible patients after risk stratification with a questionnaire.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Penicillin allergy in the patient journal oder patient reported

排除标准

  • Not able to give concent. Under 16 years of age.

结局指标

主要结局

Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge

时间窗: 24 months

Negative predictive value of the risk stratification tool

次要结局

  • Number of patients with treatment related adverse events on oral provocation testing.(24 months)
  • Number of patients correctly delabeled(24 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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