Compact Biophotonic Platform for Drug Allergy Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
研究概览
简要总结
The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device.
A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)
排除标准
- •patients with contraindications to BLC allergy work-up
- •patient refusal to enter the study
- •vulnerable patients according to French regulation
结局指标
主要结局
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
时间窗: up to 1 hour
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
时间窗: up to 1 hour
次要结局
未报告次要终点