Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,252
- 试验地点
- 2
- 主要终点
- Assessment of the new simplified drug provocation test
研究概览
简要总结
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.
investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with positive Drug Provocation Test (DPT) to beta-lactams
排除标准
- •contra-indications to DPT
- •refusal of participation
- •vulnerable patients according to French regulation
结局指标
主要结局
Assessment of the new simplified drug provocation test
时间窗: up to 1 hour
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
次要结局
未报告次要终点