Diagnosing Drug Allergy: the T is the Key (TAT)

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Amoxicillin Allergy

Treatments: Device: T-cell activation test using intracellular markers

Study type: Interventional

Funder types: Other

Identifiers

NCT06409884

003220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Patients with a suspected amoxicillin allergy

Experimental group

Description:

Patients with a suspected amoxicillin allergy for which the diagnostic work-up was performed at the hospital for the possible diagnosis of amoxicillin allergy.

Treatment:

Device: T-cell activation test using intracellular markers