Predictive Models for Betalactam Allergy

Completed

• Conditions: Drug Hypersensitivity

• Registration Number: NCT03076749
• Lead Sponsor: University Hospital, Montpellier

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 Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study Start: 2013-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-10
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines

Exclusion Criteria

• patient refusal to take part in the study
• pregnancy
• breast feeding women
• contraindication to provocation test

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Provocation test	18 months	Results of provocation test for allergy diagnosis

Secondary Outcome Measures

Name	Time	Method
Questionnaire SF36	18 months	Questionnaire SF36 will be compared to provocation test results
Questionnaire ENDA	18 months	Questionnaire ENDA will be compared to provocation test results