Diagnosing Drug Allergy: the T is the Key
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: T-cell activation test using intracellular markers.
- Кому может быть актуально
- Состояния в реестре: Amoxicillin Allergy. Базовые параметры: от 6 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Diagnosing Drug Allergy the T is the Key
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство T-cell activation test using intracellular markers
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.
Первичные конечные точки
- Sensitivity and specificity of the T-cell activation test [Срок оценки: Baseline]
Вторичные конечные точки (12)
- Positive predictive value (PPV) and negative predictive value (NPV), accuracy and likelihood ratio (LR) [Срок оценки: Baseline]
- Percentage of cases with a positive TAT and positive IgE and/or skin test [Срок оценки: Baseline]
- Association between the severity of the index reaction and the performance of TAT in terms of odds ratio. [Срок оценки: Baseline]
- Association between the time since the index reaction and the performance of TAT in terms of odds ratio. [Срок оценки: Basline]
- Association between IDHR/non-IDHR and the performance of TAT in terms of odds ratio. [Срок оценки: Baseline]
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker CD154. [Срок оценки: Baseline]
- Association between the severity of the index reaction and the net percentage of intracellular T-cell activation marker IL-4. [Срок оценки: Baseline]
- Association between the severity of the index reaction and the net percentage of cytokine IFN-γ. [Срок оценки: Baseline]
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker CD154. [Срок оценки: Baseline]
- Association between the time since the index reaction and the net percentage of intracellular T-cell activation marker IL-4. [Срок оценки: Baseline]
- Association between the time since the index reaction and the net percentage of cytokine IFN-γ. [Срок оценки: Baseline]
- Association between IDHR / non-IDHR and the net percentage of intracellular T-cell activation marker CD154. [Срок оценки: Baseline]
Критерии участия
Критерии включения
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
Критерии исключения
- Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent
- Pregnant women
- Breastfeeding women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Бельгия · 1 центр
- Antwerp University Hospital — Edegem
Идентификаторы
NCT: NCT06409884 · 003220