NCT06414694Enrolling By Invitation4 期
Inpatient Penicillin Delabeling for Low-Risk Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Direct Oral Challenge
研究概览
简要总结
This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.
详细描述
This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.
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
- 2 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >2 years
- •Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy
排除标准
- •Female patients aged >8 years of age
- •Patients with hemodynamic instability
- •Patients identified with moderate or high risk histories per protocol
- •Patients currently taking oral antihistamines in 48 hours prior to direct challenge
- •Patients currently taking oral steroids in 48 hours prior to direct challenge
- •Patients currently receiving medications for nausea, shortness of breath,
结局指标
主要结局
Direct Oral Challenge
时间窗: 2 hours
Pass or Failure of direct oral challenge
次要结局
- Follow-up at 48(48 hours)
- Follow-up at 6 months(6 months)
研究者
研究点 (2)
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