Drug HypersensitivityNCT03076749
Predictive Models for Betalactam Allergy
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Creating models for the diagnosis of BL allergy
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
Who may be able to join
- Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
Who cannot join
- patient refusal to take part in the study
- pregnancy
- breast feeding women
- contraindication to provocation test
About this study
Official title: Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®
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.
- Conditions
- Drug Hypersensitivity
- Being tested
- Creating models for the diagnosis of BL allergy
- Keywords
- Betalactam, Decision tree, Drug hypersensitivity, Logistic regression, Predictive modelling
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creating models for the diagnosis of BL allergyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocation test
Results of provocation test for allergy diagnosis
Measured: 18 months
Secondary outcomes (2)
Questionnaire SF36
Questionnaire SF36 will be compared to provocation test results
Measured: 18 months
Questionnaire ENDA
Questionnaire ENDA will be compared to provocation test results
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startFeb 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076749
- Sponsor's protocol ID
- 8927
- Other IDs
- 2012-A00182-41
- Status last verified
- Feb 2012
- First submitted
- 9 Sep 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®
- ClinicalTrials.gov ID
- NCT03076749
- Acronym / sponsor ID
- 8927
- Conditions
- Drug Hypersensitivity
- Keywords
- Betalactam, Decision tree, Drug hypersensitivity, Logistic regression, Predictive modelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
Key inclusion criteria (1 listed)
- Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines
Key exclusion criteria (4 listed)
- patient refusal to take part in the study
- pregnancy
- breast feeding women
- contraindication to provocation test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creating models for the diagnosis of BL allergy | Other | – |
Primary outcome
Provocation test
Time frame: 18 months
Results of provocation test for allergy diagnosis
2 secondary outcomes
Questionnaire SF36
Time frame: 18 months
Questionnaire ENDA
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provocation test (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.