Tick-borne Illness and Clothing Study

Tick Bites Clinical Trial

— TICS  

Official title:

Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454414
• Other study ID #: 10-1027
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tick Bites
• Tick-borne Illness

Intervention

Other:
• Permethrin Impregnated Uniforms
Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.

Locations

Country	Name	City	State
United States	Gillings School of Global Public Health	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vaughn MF, Funkhouser SW, Lin FC, Fine J, Juliano JJ, Apperson CS, Meshnick SR. Long-lasting permethrin impregnated uniforms: A randomized-controlled trial for tick bite prevention. Am J Prev Med. 2014 May;46(5):473-80. doi: 10.1016/j.amepre.2014.01.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Related Tick Bites	Tick bites are defined as ticks attached to or embedded in the skin	Weekly for two years
Secondary	Seroconversion Against a Tick-borne Illness	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).	Upon enrollment, after the first year, and after the second year