Tick-borne Illness and Clothing Study of Rhode Island
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Number of Work Related Tick Bites Per Week
研究概览
简要总结
Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and the surrounding area that will address the following study aims: 1) Evaluate the effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI clothing.
详细描述
Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. In a double-blind randomized controlled trial (RCT) in North Carolina outdoor workers, the investigators previously showed that long-lasting permethrin-impregnated (LLPI) clothing provided >80% protection for one year against Lone Star tick bites among outdoor workers in North Carolina. But there are three issues that need to be addressed before this finding can be translated into policy: 1) Do LLPI clothing protect against black legged ticks, the vector for Lyme disease, babesiosis and anaplasmosis? 2) What levels of permethrin and its metabolites are absorbed, and are they potentially toxic? 3) Why did the LLPI clothing in our previous study lose efficacy after a year?
Participants: The investigators will recruit 250 outdoor workers. The investigators anticipate recruiting 80, 80, 40,30, and 20 participants from NationalGrid, the RI Department of Environmental Management, the Massachusetts Department of Conservation & Recreation, the National Park Service, and the US Fish & Wildlife Service.
Procedures (methods): This will be a randomized controlled trial. All study subjects will fill out weekly tick logs, collect attached ticks for later speciation and pathogen detection, and submit annual serum samples to test for exposure to tick-borne pathogens. A randomly selected subset of 60 subjects also will be asked to submit urine samples for permethrin metabolite analysis at several time points during follow-up. An additional randomly selected subset (n=30) will be asked to submit worn items of clothing for tick knockdown testing and permethrin content analysis at the end of the first and second years of field testing.
The results of this study could help protect hundreds of thousands of outdoor workers with exposure to ticks and tick-borne pathogens.
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
- Double (Participant, Investigator)
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
- •over 18 years of age,
- •spending an average of 10 or more hours of outdoor work per week during peak tick season, and
- •completion of written informed consent.
排除标准
- •pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved),
- •non-English speakers, or
- •having a known allergy or sensitivity to insecticides
结局指标
主要结局
Number of Work Related Tick Bites Per Week
时间窗: Weekly for two years
Reported tick bites, defined as ticks attached to or embedded in the skin.
次要结局
- Change in permethrin metabolite levels after 3 weeks(Enrollment to 3 weeks after study initiation)
- Change in tick repellency after 2 years(Enrollment to 2 years after study initiation)
- Change in permethrin metabolite levels after 1 year(Enrollment to end of study year 1)
- Change in concentration of permethrin in clothing after 2 years(Enrollment to 2 years after study initiation)
- Change in concentration of permethrin in clothing after 1 year(Enrollment to end of study year 1)
- Change in tick repellency after 1 year(Enrollment to 1 year after study initiation)
- Pathogen seroconversion in study year 1(Enrollment to year 1)
- Pathogen seroconversion in study year 2(Study year 1 to study year 2)