NCT02613585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

November 20, 2015

Last Update Submit

March 8, 2021

Conditions

Tick BitesTick-borne Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of Work Related Tick Bites Per Week

    Reported tick bites, defined as ticks attached to or embedded in the skin.

    Weekly for two years

Secondary Outcomes (8)

  • Change in permethrin metabolite levels after 3 weeks

    Enrollment to 3 weeks after study initiation

  • Change in permethrin metabolite levels after 1 year

    Enrollment to end of study year 1

  • Change in concentration of permethrin in clothing after 1 year

    Enrollment to end of study year 1

  • Change in concentration of permethrin in clothing after 2 years

    Enrollment to 2 years after study initiation

  • Change in tick repellency after 1 year

    Enrollment to 1 year after study initiation

  • +3 more secondary outcomes

Study Arms (2)

Permethrin Impregnated Clothing

EXPERIMENTAL

Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield.

Other: Permethrin Impregnated Clothing

Untreated Clothing

NO INTERVENTION

Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied).

Interventions

Permethrin Impregnated ClothingOTHER

Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.

Also known as: Insect Shield
Permethrin Impregnated Clothing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Related Links

MeSH Terms

Conditions

Tick BitesTick-Borne Diseases

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and InjuriesVector Borne DiseasesInfections

Study Officials

  • Steven R Meshnick, MD, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

February 1, 2016

Primary Completion

March 1, 2019

Study Completion

December 1, 2020

Last Updated

March 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)