Tick BitesTICSNCT01454414
Tick-borne Illness and Clothing Study
A study testing Permethrin Impregnated Uniforms in people with Tick Bites and Tick-borne Illness, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tick Bites, Tick-borne Illness
- What is being tested?
- Permethrin Impregnated Uniforms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Non-English speaking
- Known allergy to insecticides
Trial locations and contacts
1 site in 1 country.
United States1 site
Gillings School of Global Public Health
Chapel Hill, North Carolina, 27599
About this study
Official title: Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers
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.
- Conditions
- Tick Bites, Tick-borne Illness
- Being tested
- Permethrin Impregnated Uniforms
- Medical subject headings
- Tick Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin Impregnated UniformsOther
Also called Insect Shield
Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Permethrin Impregnated Uniforms | Experimental | Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. Receives: Other: Permethrin Impregnated Uniforms |
| Placebo | No intervention | Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Related Tick Bites
Tick bites are defined as ticks attached to or embedded in the skin
Measured: Weekly for two years
Secondary outcomes (1)
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).
Measured: Upon enrollment, after the first year, and after the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tick BitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State University
- Responsible party
- Sponsor
- Investigators
- Steven R Meshnick, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454414
- Sponsor's protocol ID
- 10-1027
- Acronym
- TICS
- Status last verified
- May 2014
- First submitted
- 10 Oct 2011
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24745637
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers
- ClinicalTrials.gov ID
- NCT01454414
- Acronym / sponsor ID
- TICS / 10-1027
- Conditions
- Tick Bites, Tick-borne Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina State University
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permethrin Impregnated Uniforms | Experimental | Other: Permethrin Impregnated UniformsUniforms (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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Non-English speaking
- Known allergy to insecticides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin Impregnated UniformsAlso: Insect ShieldUniforms treated with permethrin according to proprietary process used by Insect Shield, Inc. | Other | Permethrin Impregnated Uniforms |
Primary outcome
Work Related Tick Bites
Time frame: Weekly for two years
Tick bites are defined as ticks attached to or embedded in the skin
1 secondary outcome
Seroconversion Against a Tick-borne Illness
Time frame: Upon enrollment, after the first year, and after the second year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24745637Vaughn 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Meshnick, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permethrin Impregnated Uniforms in people with Tick Bites and Tick-borne Illness, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Related Tick Bites (time frame: Weekly for two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.