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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Conditions
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
Primary outcomes
-
Provocation test
Time frame: 18 months
Results of provocation test for allergy diagnosis
Secondary outcomes
-
Questionnaire SF36
Time frame: 18 months
Questionnaire SF36 will be compared to provocation test results
-
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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