Tick-borne Illness and Clothing Study (TICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454414
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
North Carolina State University
Information provided by (Responsible Party):
Steven Meshnick, MD, PhD, University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Tick Bites Tick-borne Illness Other: Permethrin Impregnated Uniforms Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Work Related Tick Bites [ Time Frame: Weekly for two years ]
    Tick bites are defined as ticks attached to or embedded in the skin

Secondary Outcome Measures :
  1. Seroconversion Against a Tick-borne Illness [ Time Frame: Upon enrollment, after the first year, and after the second year ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01454414

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
Principal Investigator: Steven R Meshnick, MD, PhD University of North Carolina, Chapel Hill

Additional Information:
Publications of Results:
Responsible Party: Steven Meshnick, MD, PhD, Director, Infectious Disease Epidemiology Program, University of North Carolina, Chapel Hill Identifier: NCT01454414     History of Changes
Other Study ID Numbers: 10-1027
First Posted: October 19, 2011    Key Record Dates
Results First Posted: June 30, 2014
Last Update Posted: June 30, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Tick Bites
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action