Tick-borne Illness and Clothing Study (TICS)
|ClinicalTrials.gov Identifier: NCT01454414|
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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).
- Work Related Tick Bites [ Time Frame: Weekly for two years ]Tick bites are defined as ticks attached to or embedded in the skin
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454414
|United States, North Carolina|
|Gillings School of Global Public Health|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Steven R Meshnick, MD, PhD||University of North Carolina, Chapel Hill|