Diagnosing Drug Allergy the T is the Key
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of the T-cell activation test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent
- •Pregnant women
- •Breastfeeding women
研究组 & 干预措施
Patients with a suspected amoxicillin allergy
Patients with a suspected amoxicillin allergy for which the diagnostic work-up was performed at the hospital for the possible diagnosis of amoxicillin allergy.
干预措施: T-cell activation test using intracellular markers (Device)
结局指标
主要结局
Sensitivity and specificity of the T-cell activation test
时间窗: Baseline
Sensitivity and specificity of the T-cell activation test during Study Visit 1 of patients with amoxicillin allergy and control subjects without amoxicillin allergy.
次要结局
- Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR)(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)
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker CD154.(Baseline)
- Percentage of cases with a positive TAT and positive IgE and/or skin test(Baseline)
- Association between the time since the index reaction and the net percentage of cytokine IFN-γ.(Baseline)
- Association between the severity of the index reaction and the net percentage of cytokine IFN-γ.(Baseline)
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker CD154.(Baseline)
- Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker CD154.(Baseline)
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker IL-4.(Baseline)
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker IL-4.(Baseline)
- Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker IL-4.(Baseline)
- Association between IDHR / non-IDHR and the net percentage of cytokine IFN-γ.(Baseline)
- Sensitivity and specificity of TAT in subgroup of cases and controls with immediate and nonimmediate reactors(Baseline)