NCT03076749

Predictive Models for Betalactam Allergy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Drug Hypersensitivity

Interventions

Type	Name	Description
OTHER	Creating models for the diagnosis of BL allergy

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2017-03-10
• Last updated: 2017-03-10