Predictive Models for Betalactam Allergy

Drug Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076749
• Other study ID #: 8927
• Secondary ID: 2012-A00182-41
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: March 9, 2017
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Creating models for the diagnosis of BL allergy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provocation test	Results of provocation test for allergy diagnosis	18 months
Secondary	Questionnaire SF36	Questionnaire SF36 will be compared to provocation test results	18 months
Secondary	Questionnaire ENDA	Questionnaire ENDA will be compared to provocation test results	18 months