Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Prevalence of Penicillin allergy in the studied group
研究概览
简要总结
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.
详细描述
Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions.
In this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.
- •The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.
排除标准
- •Systemic reactions such as DRESS, any internal organ involvement
- •Clinical history of Type II-III hypersensitivity reaction
- •Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis
- •Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment
- •Medication which can affect the test outcome
- •Active signs of an underlying disease such as uncontrolled asthma
- •Cardiac disease with increased risk of serious anaphylaxis
- •Pregnancy/Breastfeeding
- •Reaction within the last 4-6 weeks
研究组 & 干预措施
Patients labeled as penicillin allergic
Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.
干预措施: Allergy work-up (Diagnostic Test)
Patients labeled as penicillin allergic
Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.
干预措施: Blood samples (Other)
结局指标
主要结局
Prevalence of Penicillin allergy in the studied group
时间窗: up to 4 years
Frequency of true penicillin allergy in the study group
Negative predictive value of the allergy work- up
时间窗: 3 weeks
If the allergy work-up is negative, drug provocation test with penicillin will be performed. The purpose of the drug challenge is to confirm lack of allergy and confirm the negative predictive value of the allergy work-up.
次要结局
- Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.(12 months)
研究者
Eva Stylianou
Principal Investigator
Oslo University Hospital