Predictive Models for Betalactam Allergy
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|ClinicalTrials.gov Identifier: NCT03076749|
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
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.
|Condition or disease||Intervention/treatment|
|Drug Hypersensitivity||Other: Creating models for the diagnosis of BL allergy|
|Study Type :||Observational|
|Actual Enrollment :||1200 participants|
|Official Title:||Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
- Provocation test [ Time Frame: 18 months ]Results of provocation test for allergy diagnosis
- 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