Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit
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:
-
A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
-
A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
-
A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.
-
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
- 是
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)
