Diagnosing Drug Allergy: the T is the Key
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-cell activation test using intracellular markers.
- Who it may be relevant to
- Registry conditions: Amoxicillin Allergy. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnosing Drug Allergy the T is the Key
Overview
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.
Detailed description
Drug allergy is a significant health issue with a serious medical and financial burden of mis- and overdiagnosis. Currently applied tests differ for immediate and nonimmediate drug allergy and have variable sensitivity and specificity. Therefore, correct diagnosis remains difficult and frequently requires potentially dangerous and time-consuming challenge tests. Drug-specific T-cells play a central role in initiation and maintenance of both immediate and nonimmediate drug allergy and can be studied in the lymphocyte transformation test (LTT). However, technical difficulties have hindered entrance of the LTT in mainstream use. The investigators' data indicates that flow-based intracellular trapping and staining of markers induced during activation (such as CD154 and cytokines) enables a rapid enumeration of rare drug-specific T-cells in the blood of patients with immediate and nonimmediate amoxicillin allergy. The ambition of this project is to validate a "one fits all" assay that meets the requirements of a safe, patient friendly, accessible, and performant test that could merits the status of a primary investigation in the diagnostic algorithms. Moreover, as the tests is cost effective, it could also become an attractive method for broader applications such as the delabelling of spurious allergies. This project will focus on allergy to amoxicillin.
Interventions
- Device T-cell activation test using intracellular markers
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.
Primary outcome measures
- Sensitivity and specificity of the T-cell activation test [Time frame: Baseline]
Secondary outcome measures (12)
- Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR) [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. [Time frame: Baseline]
- Association between the time since the index reaction and the performance of TAT in terms of odds ratio. [Time frame: Basline]
- Association between IDHR/non-IDHR and the performance of TAT in terms of odds ratio. [Time frame: Baseline]
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker CD154. [Time frame: Baseline]
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker IL-4. [Time frame: Baseline]
- Association between the severity of the index reaction and the net percentage of cytokine IFN-γ. [Time frame: Baseline]
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker CD154. [Time frame: Baseline]
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker IL-4. [Time frame: Baseline]
- Association between the time since the index reaction and the net percentage of cytokine IFN-γ. [Time frame: Baseline]
- Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker CD154. [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
Participants are eligible if they:
- 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
Exclusion criteria
- Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent
- Pregnant women
- Breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Antwerp University Hospital — Edegem
Identifiers
NCT: NCT06409884 · 003220