NCT03076749

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
Last Updated

March 10, 2017

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

September 9, 2016

Last Update Submit

March 9, 2017

Conditions

Drug Hypersensitivity

Keywords

BetalactamDecision treeDrug hypersensitivityLogistic regressionPredictive modelling

Outcome Measures

Primary Outcomes (1)

  • Provocation test

    Results of provocation test for allergy diagnosis

    18 months

Secondary Outcomes (2)

  • Questionnaire SF36

    18 months

  • Questionnaire ENDA

    18 months

Interventions

Creating models for the diagnosis of BL allergyOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines

You may qualify if:

  • Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines

You may not qualify if:

  • patient refusal to take part in the study
  • pregnancy
  • breast feeding women
  • contraindication to provocation test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

March 10, 2017

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 10, 2017

Record last verified: 2012-02

Data Sharing

IPD Sharing
Will not share