Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
研究概览
简要总结
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
详细描述
all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior history of PCN allergy
排除标准
- •No immunodeficiency or contraindication to skin testing
研究组 & 干预措施
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
干预措施: Penicillin Major Determinant (PrePen) Skin Testing (Drug)
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
干预措施: Direct Oral challenge (Drug)
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
干预措施: Direct Oral challenge (Drug)
结局指标
主要结局
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
时间窗: Baseline
Used yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm
Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge
时间窗: 30 minutes after intervention
Safety was determined by the presence or absence of adverse reactions. Symptoms assessed included pruritis, flushing, shortness of breath. Physical examination included vital signs, blood pressure, pulse, respiratory rate and peak expiratory flow
次要结局
- Provider Assessment of Feasibility of Allergy Evaluation at the End of Study(18 months)
- Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire(Immediately after intervention)