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Predictive Models for Betalactam Allergy

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Drug Hypersensitivity

Treatments

Other: Creating models for the diagnosis of BL allergy

Study type

Observational

Funder types

Other

Identifiers

NCT03076749
2012-A00182-41 (Other Identifier)
8927

Details and patient eligibility

About

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.

Enrollment

1,200 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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