Clinical Trial: Predictive Models for Betalactam Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.


Detailed Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome: Provocation test [ Time Frame: 18 months ]

Results of provocation test for allergy diagnosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Questionnaire SF36 [ Time Frame: 18 months ]
    Questionnaire SF36 will be compared to provocation test results
  • Questionnaire ENDA [ Time Frame: 18 months ]
    Questionnaire ENDA will be compared to provocation test results


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: September 9, 2016
Date Started: February 2013
Date Completion:
Last Updated: March 9, 2017
Last Verified: February 2012