Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Incidence of Lyme disease
研究概览
简要总结
Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?
This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.
详细描述
This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.
Subjects (N=200) will be recruited from camp staff to participate in the study and screened by inclusion and exclusion criteria.Qualifying subjects will be randomized to either the treatment (N=100) or non-treatment arm (N=100).
Subjects in the treatment arm will have their scout shorts, pants, and socks sprayed with 0.5% permethrin and allowed to dry. Subjects in the non-treatment arm will have their scout shorts, pants, and socks sprayed with water and allowed to dry.
Subjects will then be followed over the summer camping season to see if they develop Lyme disease. At 70 days, all subjects will have their Lyme titers rechecked to ensure that all cases of Lyme disease were documented.
Following the 70 day visit, there will be an assessment of the final study outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Summer camp staff at Tomahawk Scout Reservation
- •Works in an outdoor environment
- •Sleeps in an outdoor environment (platform tent)
- •Present for the entire camp season (June - August)
- •Informed consent
排除标准
- •Contraindication, allergy or previous reaction to permethrin
- •Inability of subject or surrogate (e.g., parent if < 18 years of age) to provide informed consent
结局指标
主要结局
Incidence of Lyme disease
时间窗: Day <=70
次要结局
未报告次要终点