Predictive Models for Betalactam Allergy

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Hypersensitivity
• Intervention / Treatment: Other: Creating models for the diagnosis of BL allergy

• Study Type: Observational
• Enrollment (Actual): 1200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provocation test	Results of provocation test for allergy diagnosis	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire SF36	Questionnaire SF36 will be compared to provocation test results	18 months
Questionnaire ENDA	Questionnaire ENDA will be compared to provocation test results	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Drug hypersensitivity; Betalactam; Decision tree; Logistic regression; Predictive modelling
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: 8927; 2012-A00182-41 (Other Identifier: Agence Francaise de securité sanitaire des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No