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Predictive Models for Betalactam Allergy

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ClinicalTrials.gov Identifier: NCT03076749
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Drug Hypersensitivity Other: Creating models for the diagnosis of BL allergy

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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Provocation test [ Time Frame: 18 months ]
    Results of provocation test for allergy diagnosis


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
Criteria

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

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03076749     History of Changes
Other Study ID Numbers: 8927
2012-A00182-41 ( Other Identifier: Agence Francaise de securité sanitaire des produits de santé )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: February 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
Betalactam
Decision tree
Drug hypersensitivity
Logistic regression
Predictive modelling
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents