Trial Outcomes & Findings for Tick-borne Illness and Clothing Study (NCT NCT01454414)
NCT ID: NCT01454414
Last Updated: 2021-03-30
Results Overview
Tick bites are defined as ticks attached to or embedded in the skin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
Weekly for two years
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
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.
|
Placebo
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
80
|
|
Overall Study
Baseline: Subjects That Sent Uniforms
|
67
|
66
|
|
Overall Study
COMPLETED
|
66
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tick-borne Illness and Clothing Study
Baseline characteristics by cohort
| Measure |
Permethrin Impregnated Uniforms
n=67 Participants
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.
|
Placebo
n=66 Participants
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
38.8 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
39.0 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
14 participants
n=99 Participants
|
11 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
52 participants
n=99 Participants
|
55 participants
n=107 Participants
|
107 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
56 participants
n=99 Participants
|
58 participants
n=107 Participants
|
114 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education, categorical
High school or less
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Education, categorical
Some college
|
20 participants
n=99 Participants
|
14 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Education, categorical
Bachelor or graduate degree
|
40 participants
n=99 Participants
|
42 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Work division, categorical
NC Forest service
|
21 participants
n=99 Participants
|
27 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Work division, categorical
NC Division of Parks and Recreation
|
31 participants
n=99 Participants
|
25 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Work division, categorical
NC Wildlife Resources Commission
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Work division, categorical
NC Local or County Parks and Recreation
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Years in current position, continuous
|
7.9 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
8.2 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
8.0 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Tick bites in previous year, continuous
|
19.3 tick bites
STANDARD_DEVIATION 32.0 • n=99 Participants
|
19.6 tick bites
STANDARD_DEVIATION 39.3 • n=107 Participants
|
19.4 tick bites
STANDARD_DEVIATION 35.8 • n=206 Participants
|
|
Previous diagnosis with tick-borne illness
Lyme disease
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Previous diagnosis with tick-borne illness
Rocky Mountain spotted fever
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Previous diagnosis with tick-borne illness
Ehrlichiosis
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Previous diagnosis with tick-borne illness
Anaplasmosis
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Previous diagnosis with tick-borne illness
Babesiosis
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Long pants
|
62 participants
n=99 Participants
|
62 participants
n=107 Participants
|
124 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Long sleeves
|
48 participants
n=99 Participants
|
52 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Hat
|
43 participants
n=99 Participants
|
38 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Tucked or taped pant legs
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Repellent on skin
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Repellent on clothing
|
38 participants
n=99 Participants
|
35 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Use of tick bite prevention measures
Tick checks after working outdoors
|
58 participants
n=99 Participants
|
60 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Use of self-applied permethrin on clothing
|
30 participants
n=99 Participants
|
34 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weekly for two yearsTick bites are defined as ticks attached to or embedded in the skin
Outcome measures
| Measure |
Permethrin Impregnated Uniforms
n=66 Participants
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.
|
Placebo
n=64 Participants
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
|
|---|---|---|
|
Work Related Tick Bites
|
265 tick bites
|
780 tick bites
|
SECONDARY outcome
Timeframe: Upon enrollment, after the first year, and after the second yearWe 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).
Outcome measures
Outcome data not reported
Adverse Events
Permethrin Impregnated Uniforms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Permethrin Impregnated Uniforms
n=67 participants at risk
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.
|
Placebo
n=66 participants at risk
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
|
|---|---|---|
|
Infections and infestations
Tick-borne illness (serologically confirmed)
|
0.00%
0/67
|
3.0%
2/66 • Number of events 2
|
Additional Information
Dr. Meagan Vaughn
University of North Carolina at Chapel Hill
Phone: 9196986208
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place