Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 主要终点
- Provocation test
研究概览
简要总结
Background: ß-lactam (BL) antibiotics represent the main cause of allergic reactions to drugs, inducing both immediate and non-immediate reactions. The diagnosis is well established, usually based upon skin tests and drug provocation tests, but cumbersome.
Objectives: To design predictive models for the diagnosis of BL allergy, based on the clinical history of patients with suspicions of allergic reactions to BL.
Methods: The study included a retrospective phase in which records of patients consulting and explored for a suspicion of BL allergy (in the Allergy Unit of the University Hospital of Montpellier between September 1996 and September 2012) where used to construct predictive models; a prospective phase, in which we performed an external validation of the chosen models, in patients with suspicion of BL allergy recruited from 3 allergy centres (Montpellier, Nîmes, Narbonne), between March and November 2013. Data related to clinical history and allergy work-up results were retrieved and analysed. Logistic regression and decision tree method were used to design two models to predict the diagnosis of allergy to BL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
排除标准
- •patient refusal to take part in the study
- •pregnancy
- •breast feeding women
- •contraindication to provocation test
结局指标
主要结局
Provocation test
时间窗: 18 months
Results of provocation test for allergy diagnosis
次要结局
- Questionnaire SF36(18 months)
- Questionnaire ENDA(18 months)
