Tick BitesNCT02613585
Tick-borne Illness and Clothing Study of Rhode Island
A study testing Permethrin Impregnated Clothing in people with Tick Bites and Tick-borne Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tick Bites, Tick-borne Diseases
- What is being tested?
- Permethrin Impregnated Clothing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
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.
Read the 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.
- Conditions
- Tick Bites, Tick-borne Diseases
- Being tested
- Permethrin Impregnated Clothing
- Medical subject headings
- Tick Bites, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin Impregnated ClothingOther
Also called Insect Shield
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Permethrin Impregnated Clothing | Experimental | Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield. Receives: Other: Permethrin Impregnated Clothing |
| Untreated Clothing | No intervention | Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Work Related Tick Bites Per Week
Reported tick bites, defined as ticks attached to or embedded in the skin.
Measured: Weekly for two years
Secondary outcomes (8)
Change in permethrin metabolite levels after 3 weeks
Permethrin metabolites measured in urine, compared to baseline prior to wearing clothing.
Measured: Enrollment to 3 weeks after study initiation
Change in permethrin metabolite levels after 1 year
Metabolites measured in urine, compared to baseline prior to wearing clothing.
Measured: Enrollment to end of study year 1
Change in concentration of permethrin in clothing after 1 year
Measurement of the chemical concentration of clothing samples after study year 1, compared against concentration of a newly treated clothing sample.
Measured: Enrollment to end of study year 1
Change in concentration of permethrin in clothing after 2 years
Measurement of the chemical concentration of clothing samples after study year 2, compared against concentration of a newly treated clothing sample.
Measured: Enrollment to 2 years after study initiation
Change in tick repellency after 1 year
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.
Measured: Enrollment to 1 year after study initiation
Change in tick repellency after 2 years
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.
Measured: Enrollment to 2 years after study initiation
Pathogen seroconversion in study 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.
Measured: Enrollment to year 1
Pathogen seroconversion in 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.
Measured: Study year 1 to study year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionMar 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick BitesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island, East Carolina University, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Steven R Meshnick, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613585
- Sponsor's protocol ID
- 15-1770
- Other IDs
- R01OH010791
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2015
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tick-borne Illness and Clothing Study of Rhode Island
- ClinicalTrials.gov ID
- NCT02613585
- Acronym / sponsor ID
- 15-1770
- Conditions
- Tick Bites, Tick-borne Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Rhode Island, East Carolina University, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permethrin Impregnated Clothing | Experimental | Other: Permethrin Impregnated ClothingUniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield. |
| Untreated Clothing | No intervention | –Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin Impregnated ClothingAlso: Insect ShieldUniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc. | Other | Permethrin Impregnated Clothing |
Primary outcome
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.
8 secondary outcomes
Change in permethrin metabolite levels after 3 weeks
Time frame: Enrollment to 3 weeks after study initiation
Change in permethrin metabolite levels after 1 year
Time frame: Enrollment to end of study year 1
Change in concentration of permethrin in clothing after 1 year
Time frame: Enrollment to end of study year 1
Change in concentration of permethrin in clothing after 2 years
Time frame: Enrollment to 2 years after study initiation
Change in tick repellency after 1 year
Time frame: Enrollment to 1 year after study initiation
Change in tick repellency after 2 years
Time frame: Enrollment to 2 years after study initiation
Pathogen seroconversion in study year 1
Time frame: Enrollment to year 1
Pathogen seroconversion in study year 2
Time frame: Study year 1 to study year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- A prior study, Tick-borne Illness and Clothing Study (TICS), was conducted in North Carolina by UNC. The current study uses similar methodology as described in the NC study, as it applies to outdoor workers and ticks in the Rhode Island area.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Meshnick, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permethrin Impregnated Clothing in people with Tick Bites and Tick-borne Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Work Related Tick Bites Per Week (time frame: Weekly for two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.