Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
NCT ID: NCT00958139
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
61 participants
INTERVENTIONAL
2008-06-30
2008-10-31
Brief Summary
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This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.
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Detailed Description
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Subjects (N=200) will be recruited from camp staff to participate in the study and screened by inclusion and exclusion criteria.Qualifying subjects will be randomized to either the treatment (N=100) or non-treatment arm (N=100).
Subjects in the treatment arm will have their scout shorts, pants, and socks sprayed with 0.5% permethrin and allowed to dry. Subjects in the non-treatment arm will have their scout shorts, pants, and socks sprayed with water and allowed to dry.
Subjects will then be followed over the summer camping season to see if they develop Lyme disease. At 70 days, all subjects will have their Lyme titers rechecked to ensure that all cases of Lyme disease were documented.
Following the 70 day visit, there will be an assessment of the final study outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Permethrin treatment of clothing
0.5% permethrin sprayed one time on uniform shorts, pants, and socks
Permethrin
Permethrin 0.5% treatment of clothing one time
Placebo
Water sprayed on uniform shorts, pants, and socks
Placebo
water sprayed on clothing one time
Interventions
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Permethrin
Permethrin 0.5% treatment of clothing one time
Placebo
water sprayed on clothing one time
Eligibility Criteria
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Inclusion Criteria
* Works in an outdoor environment
* Sleeps in an outdoor environment (platform tent)
* Present for the entire camp season (June - August)
* Informed consent
Exclusion Criteria
* Inability of subject or surrogate (e.g., parent if \< 18 years of age) to provide informed consent
14 Years
65 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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David R. Boulware, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Tomahawk Scout Camp
Rice Lake, Wisconsin, United States
Countries
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Other Identifiers
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0804M3101
Identifier Type: -
Identifier Source: org_study_id
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