Diagnosing Drug Allergy: the T is the Key

NCT06409884 | Recruiting

• 1 other identifier: 003220
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Amoxicillin Allergy

Keywords

Amoxicillin; Amoxicillin Allergy; Allergy; T-cells

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (15)

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

  Baseline

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

  Baseline

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

  Baseline

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

  Basline

• Association between IDHR/non-IDHR and the performance of TAT in terms of odds ratio.

  Baseline

Other Outcomes (2)

• Sensitivity of TAT 1 year and 3 years after diagnosis

  After 1 and 3 years

• Evolution TAT-components over time

  After 1 and 3 years

Study Arms (1)

Patients with a suspected amoxicillin allergy

EXPERIMENTAL

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

Device: T-cell activation test using intracellular markers

Interventions

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.

Patients with a suspected amoxicillin allergy

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• AZ Jan Palfijn Gent: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Didier Ebo, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier Ebo, PhD

CONTACT

+3238215027; Didier.Ebo@uza.be

Laura Peeters, Msc

CONTACT

Laura.Peeters@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 10, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)