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OpenTrials
Completed

NCT Number: NCT03076749

Predictive Models for Betalactam Allergy

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creating models for the diagnosis of BL allergy

Other

Primary outcomes

  1. Provocation test

    Time frame: 18 months

    Results of provocation test for allergy diagnosis

Secondary outcomes

  1. Questionnaire SF36

    Time frame: 18 months

    Questionnaire SF36 will be compared to provocation test results

  2. Questionnaire ENDA

    Time frame: 18 months

    Questionnaire ENDA will be compared to provocation test results

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2017
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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