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Predictive Models for Betalactam Allergy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03076749
Enrollment
1200
Registered
2017-03-10
Start date
2013-02-28
Completion date
2014-10-31
Last updated
2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Keywords

Betalactam, Decision tree, Drug hypersensitivity, Logistic regression, Predictive modelling

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.

Interventions

OTHERCreating models for the diagnosis of BL allergy

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Provocation test18 monthsResults of provocation test for allergy diagnosis

Secondary

MeasureTime frameDescription
Questionnaire SF3618 monthsQuestionnaire SF36 will be compared to provocation test results
Questionnaire ENDA18 monthsQuestionnaire ENDA will be compared to provocation test results

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026