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Tick-borne Illness and Clothing Study (TICS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
North Carolina State University
Information provided by (Responsible Party):
Steven Meshnick, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01454414
First received: October 10, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers most at risk include, foresters, park rangers, land surveyors and other outdoor workers have frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor occupations report multiple tick bites each year, which indicates that existing tick preventive strategies may be ineffective. The principal goal of this study is to assess whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick bites sustained by North Carolina outdoor workers.


Condition Intervention
Tick Bites
Tick-borne Illness
 Other: Permethrin Impregnated Uniforms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers

Resource links provided by NLM:

Drug Information available for: Permethrin
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Tick bites [ Time Frame: Weekly for two years ] [ Designated as safety issue: No ]
    Tick bites are defined as ticks attached to or embedded in the skin


Secondary Outcome Measures:
  • Seroconversion against a tick-borne illness [ Time Frame: Upon enrollment, after the first year, and after the second year ] [ Designated as safety issue: No ]
    We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae).


Enrollment: 159
Study Start Date: October 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Permethrin Impregnated Uniforms
Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
 Other: Permethrin Impregnated Uniforms
Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Name: Insect Shield
No Intervention: Placebo
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being over 18 years of age
  • Employee of NC Division of Forest Resources, the NC Division of Parks and Recreation, NC Wildlife Resources Commission, or NC County and Local Parks and Recreation who work in Central and Eastern North Carolina
  • An average of 10 or more hours of outdoor work per week during tick season
  • Self-reported prior work-related tick bites

Exclusion Criteria:

  • Pregnancy
  • Non-English speaking
  • Known allergy to insecticides
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454414

Locations
United States, North Carolina
Gillings School of Global Public Health
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina State University
Investigators
Principal Investigator: Steven R Meshnick, MD, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
TICS Informational Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven Meshnick, Director, Infectious Disease Epidemiology Program, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01454414     History of Changes
Other Study ID Numbers: 10-1027
Study First Received: October 10, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013