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| Name | Class |
|---|---|
| North Carolina State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permethrin Impregnated Uniforms | Experimental | Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. |
|
| Placebo | No Intervention | Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permethrin Impregnated Uniforms | Other | Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Work Related Tick Bites | Tick bites are defined as ticks attached to or embedded in the skin | Weekly for two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Meshnick, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gillings School of Global Public Health | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24745637 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Permethrin Impregnated Uniforms | Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc. |
| FG001 | Placebo | Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Permethrin Impregnated Uniforms | Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Work Related Tick Bites | Tick bites are defined as ticks attached to or embedded in the skin | Posted | Number | tick bites | Weekly for two years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Permethrin Impregnated Uniforms | Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tick-borne illness (serologically confirmed) | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meagan Vaughn | University of North Carolina at Chapel Hill | 9196986208 | meagan.vaughn@unc.edu |
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| ID | Term |
|---|---|
| D064927 | Tick Bites |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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|
| Upon enrollment, after the first year, and after the second year |
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | One subject did not provide information on gender. | Number | participants |
|
| Race/Ethnicity, Customized | Sixteen subjects did not provide race or ethnicity information. | Number | participants |
|
| Education, categorical | Two subjects did not provide education information on the baseline questionnaire. | Number | participants |
|
| Work division, categorical | One subject did not provide information on work division. | Number | participants |
|
| Years in current position, continuous | Mean | Standard Deviation | years |
|
| Tick bites in previous year, continuous | Mean | Standard Deviation | tick bites |
|
| Previous diagnosis with tick-borne illness | Self-reported diagnosis with a tick-borne illness prior to enrollment in the study. | Number | participants |
|
| Use of tick bite prevention measures | Number | participants |
|
| Use of self-applied permethrin on clothing | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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). | Not Posted | Upon enrollment, after the first year, and after the second year | Participants |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Placebo | Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). | 0 | 66 | 2 | 66 |
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