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Trial record 41 of 64 for:    lyme

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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment
Tick Bites Tick-borne Diseases Other: Permethrin Impregnated 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tick Bites
Drug Information available for: Permethrin
U.S. FDA Resources

Arms and Interventions

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.
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).


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: John W Wallace, PhD, MSPH 919-962-8870 john.wallace@unc.edu

Locations
United States, Rhode Island
University of Rhode Island Recruiting
Kingston, Rhode Island, United States, 02881
Contact: Thomas Mather, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Rhode Island
East Carolina University
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
Principal Investigator: Steven R Meshnick, MD, PhD University of North Carolina, Chapel Hill
More Information

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02613585     History of Changes
Other Study ID Numbers: 15-1770
R01OH010791 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tick-Borne Diseases
Tick Bites
Gram-Negative Bacterial Infections
Bacterial Infections
Arbovirus Infections
Virus Diseases
Protozoan Infections
Parasitic Diseases
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action