Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups
研究概览
简要总结
The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.
详细描述
The PEN-FAST clinical decision rule is an internationally validated scoring system (0-5 points) that identifies low-risk patients (= a score of 0-2 points) with self-reported penicillin allergies with a negative predictive value (NPV) of over 95%. Performing direct drug provocation tests without prior skin testing on these low-risk patients was shown to be non-inferior in terms of safety and prediction of immediate allergic reactions. However, several studies have questioned the negative predictive capacity of the PEN-FAST score. In these studies, misclassifications of the PEN-FAST score were mainly based on positive skin test findings that can show false-positive results.
This study aims to validate the NPV and safety of direct drug provocation tests using the PEN-FAST score.
Participants with a PEN-FAST score of 0-2 points will directly receive a two-dose challenge (50%-50%) or single challenge (100%) with the culprit penicillin and will be monitored for at least 4 hours. No skin tests will be performed prior to the drug provocation test. Patients will be instructed to contact the hospital after the drug provocation test to monitor any delayed allergic reactions.
The outcomes will be compared to those of patients with a PEN-FAST score of 0-2 points who do not wish to skip the skin tests and who will, in parallel, receive the standard-of-care testing.
Currently, this study is approved as a single-site study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients or inpatients with a penicillin allergy label
- •Willing and able to give consent.
- •PEN-FAST score of 0-2 points
排除标准
- •Age <18 years
- •Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
- •Concurrent antihistamine therapy
- •Significantly impaired general condition
- •Unstable or therapeutically inadequately controlled bronchial asthma
- •History of stem cell transplantation
- •History of acute interstitial nephritis
- •Chronic urticaria
- •Mastocytosis
研究组 & 干预措施
Direct drug provocation test
干预措施: Direct Oral challenge (Other)
Standard of care
Standard of care Skin testing and measurement of allergen-specific IgE, if negative, drug provocation test.
干预措施: standard of care (Other)
结局指标
主要结局
The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups
时间窗: 7 days
Percentage of subjects that retain their allergy label as they show at least one positive finding in skin tests, allergen-specific IgE or drug provocation test.
次要结局
- Analysis of medical and allergic history(One day)
- Negative predictive capacity of skin tests and allergen-specific IgE(7 days)
- Penicillin allergy label(1 day)
- Analysis of demographic data(1 day)
- Analysis of adverse reactions(7 days)
- Analysis of internal hospital risk stratification system(One day)
- Analysis of medical and allergic history(1 day)
研究者
Deniz Göcebe
Dr. med. Deniz Göcebe
University Hospital Heidelberg