Clinical trial NCT06409884: Diagnosing Drug Allergy: the T is the Key
Official title: Diagnosing Drug Allergy the T is the Key
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amoxicillin Allergy
Keywords: Amoxicillin
Amoxicillin Allergy
Allergy
T-cells
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: AZ Jan Palfijn Gent
name: Universiteit Antwerpen
First posted: 2024-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Primary outcomes:
measure: Sensitivity and specificity of the T-cell activation test
timeFrame: Baseline
Secondary outcomes:
measure: Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR)
timeFrame: Baseline
measure: Percentage of cases with a positive TAT and positive IgE and/or skin test
timeFrame: Baseline
measure: Association between the severity of the index reaction and the performance of TAT in terms of odds ratio.
timeFrame: Baseline
measure: Association between the time since the index reaction and the performance of TAT in terms of odds ratio.
timeFrame: Basline
measure: Association between IDHR/non-IDHR and the performance of TAT in terms of odds ratio.
timeFrame: Baseline
measure: Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker CD154.
timeFrame: Baseline
measure: Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker IL-4.
timeFrame: Baseline
measure: Association between the severity of the index reaction and the net percentage of cytokine IFN-γ.
timeFrame: Baseline
measure: Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker CD154.
timeFrame: Baseline
measure: Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker IL-4.
timeFrame: Baseline
measure: Association between the time since the index reaction and the net percentage of cytokine IFN-γ.
timeFrame: Baseline
measure: Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker CD154.
timeFrame: Baseline
measure: Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker IL-4.
timeFrame: Baseline
measure: Association between IDHR / non-IDHR and the net percentage of cytokine IFN-γ.
timeFrame: Baseline
measure: Sensitivity and specificity of TAT in subgroup of cases and controls with immediate and nonimmediate reactors
timeFrame: Baseline
Other outcomes:
measure: Sensitivity of TAT 1 year and 3 years after diagnosis
timeFrame: After 1 and 3 years
measure: Evolution TAT-components over time
timeFrame: After 1 and 3 years
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Didier Ebo, PhD
role: PRINCIPAL_INVESTIGATOR
References: