Tick-borne Illness and Clothing Study of Rhode Island
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|ClinicalTrials.gov Identifier: NCT02613585|
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tick Bites Tick-borne Diseases||Other: Permethrin Impregnated Clothing||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Tick-borne Illness and Clothing Study of Rhode Island|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Permethrin Impregnated Clothing
Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield.
Other: Permethrin Impregnated Clothing
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Name: Insect Shield
No Intervention: Untreated Clothing
Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied).
- Number of Work Related Tick Bites Per Week [ Time Frame: Weekly for two years ]Reported tick bites, defined as ticks attached to or embedded in the skin.
- Change in permethrin metabolite levels after 3 weeks [ Time Frame: Enrollment to 3 weeks after study initiation ]Permethrin metabolites measured in urine, compared to baseline prior to wearing clothing.
- Change in permethrin metabolite levels after 1 year [ Time Frame: Enrollment to end of study year 1 ]Metabolites measured in urine, compared to baseline prior to wearing clothing.
- Change in concentration of permethrin in clothing after 1 year [ Time Frame: Enrollment to end of study year 1 ]Measurement of the chemical concentration of clothing samples after study year 1, compared against concentration of a newly treated clothing sample.
- Change in concentration of permethrin in clothing after 2 years [ Time Frame: Enrollment to 2 years after study initiation ]Measurement of the chemical concentration of clothing samples after study year 2, compared against concentration of a newly treated clothing sample.
- Change in tick repellency after 1 year [ Time Frame: Enrollment to 1 year after study initiation ]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.
- Change in tick repellency after 2 years [ Time Frame: Enrollment to 2 years after study initiation ]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.
- Pathogen seroconversion in study year 1 [ Time Frame: Enrollment to year 1 ]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.
- Pathogen seroconversion in study year 2 [ Time Frame: Study year 1 to study year 2 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613585
|Contact: John W Wallace, PhD, MSPHfirstname.lastname@example.org|
|United States, Rhode Island|
|University of Rhode Island||Recruiting|
|Kingston, Rhode Island, United States, 02881|
|Contact: Thomas Mather, PhD|
|Principal Investigator:||Steven R Meshnick, MD, PhD||University of North Carolina, Chapel Hill|