Diagnosing Drug Allergy: the T is the Key

ConditionAmoxicillin Allergy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6+

SponsorUniversity Hospital, Antwerp

About this trial

The goal of this clinical trial is to validate a newly developed test in the diagnosis of patients with amoxicillin allergy (i.e. T-cell activation test). The main questions the study aims to assess are the reliability and applicability of this test. Participants will be asked to visit the hospital 1, 3 or 5 times during which blood is collected and when applicable, allergy skin testing is performed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are ≥ 6 years

Are capable of informed consent, or if appropriate, participants have an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 18 years of age)

Have a suspected history of amoxicillin allergy

Disqualifiers

Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent

Pregnant women

Breastfeeding women

Trial design

Design model

Single group

Treatments tested in this trial

T-cell activation test using intracellular markers
Device
A blood sample will be taken which is needed for the T-cell activation test (TAT). The TAT will than be performed by trained laboratory personnel.

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Patients with a suspected amoxicillin allergyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Sensitivity and specificity of the T-cell activation test

Sensitivity and specificity of the T-cell activation test during Study Visit 1 of patients with amoxicillin allergy and control subjects without amoxicillin allergy.

Time frame

Baseline

Secondary outcomes

Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR)

Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR) of the T-cell activation test in the diagnosis of amoxicillin allergy.

Time frame

Baseline

Percentage of cases with a positive TAT and positive IgE and/or skin test

Time frame

Baseline

Association between the severity of the index reaction and the performance of TAT in terms of odds ratio.

The impact of severity of the index reaction on TAT-positivity will be studied in a logistic regression model. Odds ratios and 95% confidence intervals will be reported.

Time frame

Baseline

Association between the time since the index reaction and the performance of TAT in terms of odds ratio.

The impact of the time since the index reaction on TAT-positivity will be studied in a logistic regression model. Odds ratios and 95% confidence intervals will be reported.

Time frame

Basline

Other outcomes

Sensitivity of TAT 1 year and 3 years after diagnosis

Sensitivity of TAT 1 year and 3 years after diagnosis of patients with amoxicillin allergy

Time frame

After 1 and 3 years

Evolution TAT-components over time

Evolution TAT-components over time in patients with amoxicillin allergy

Time frame

After 1 and 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

AZ Jan Palfijn Gent

Collaborator

Universiteit Antwerpen

Collaborator

Source ClinicalTrials.gov

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