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临床试验/NCT03076749
NCT03076749已完成不适用

Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®

University Hospital, Montpellier0 个研究点目标入组 1,200 人开始时间: 2013年2月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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