- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613585
Tick-borne Illness and Clothing Study of Rhode Island
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhode Island
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Kingston, Rhode Island, United States, 02881
- University of Rhode Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Permethrin Impregnated Clothing
Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield.
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Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Names:
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No Intervention: Untreated Clothing
Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Work Related Tick Bites Per Week
Time Frame: Weekly for two years
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Reported tick bites, defined as ticks attached to or embedded in the skin.
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Weekly for two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in permethrin metabolite levels after 3 weeks
Time Frame: Enrollment to 3 weeks after study initiation
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Permethrin metabolites measured in urine, compared to baseline prior to wearing clothing.
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Enrollment to 3 weeks after study initiation
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Change in permethrin metabolite levels after 1 year
Time Frame: Enrollment to end of study year 1
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Metabolites measured in urine, compared to baseline prior to wearing clothing.
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Enrollment to end of study year 1
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Change in concentration of permethrin in clothing after 1 year
Time Frame: Enrollment to end of study year 1
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Measurement of the chemical concentration of clothing samples after study year 1, compared against concentration of a newly treated clothing sample.
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Enrollment to end of study year 1
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Change in concentration of permethrin in clothing after 2 years
Time Frame: Enrollment to 2 years after study initiation
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Measurement of the chemical concentration of clothing samples after study year 2, compared against concentration of a newly treated clothing sample.
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Enrollment to 2 years after study initiation
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Change in tick repellency after 1 year
Time Frame: Enrollment to 1 year after study initiation
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Measurement of the tick repellency ("knockdown activity") of clothing samples after study year 1, compared against concentration of a newly treated piece of clothing sample.
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Enrollment to 1 year after study initiation
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Change in tick repellency after 2 years
Time Frame: Enrollment to 2 years after study initiation
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Measurement of the tick repellency ("knockdown activity") of clothing samples after study year 2, compared against concentration of a newly treated piece of clothing sample.
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Enrollment to 2 years after study initiation
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Pathogen seroconversion in study year 1
Time Frame: Enrollment to year 1
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Seroconversion in year 1 is defined as a fourfold rise in antibody titers against pathogens of tick-borne disease when comparing titers between baseline and after year 1.
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Enrollment to year 1
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Pathogen seroconversion in study year 2
Time Frame: Study year 1 to study year 2
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Seroconversion in year 2 is defined as a fourfold rise in antibody titers against pathogens of tick-borne disease when comparing titers between baseline and after year 2.
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Study year 1 to study year 2
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven R Meshnick, MD, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-1770
- R01OH010791 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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