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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):

November 20, 2015
November 24, 2015
November 14, 2017
February 2016
August 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02613585 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Tick-borne Illness and Clothing Study of Rhode Island
Tick-borne Illness and Clothing Study of Rhode Island
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Tick Bites
  • Tick-borne Diseases
Other: Permethrin Impregnated Clothing
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Name: Insect Shield
  • Experimental: Permethrin Impregnated Clothing
    Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield.
    Intervention: Other: Permethrin Impregnated Clothing
  • No Intervention: Untreated Clothing
    Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2019
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: John W Wallace, PhD, MSPH 919-962-8870 john.wallace@unc.edu
United States
 
 
NCT02613585
15-1770
R01OH010791 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • University of Rhode Island
  • East Carolina University
  • National Institute for Occupational Safety and Health (NIOSH/CDC)
Principal Investigator: Steven R Meshnick, MD, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP