Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409884
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-17
Brief Title:
Diagnosing Drug Allergy the T is the Key
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Diagnosing Drug Allergy the T is the Key
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAT
Brief Summary:
The goal of this clinical trial is to validate a newly developed test in the diagnosis of patients with amoxicillin allergy ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None