Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lyme Disease
Intervention: Permethrin (Other); Placebo (Other)
Phase: Phase 3
Status: Terminated
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s): David R. Boulware, MD, MPH, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute
Summary
Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?
This is a double-blind, randomized clinical trial using permethrin treatment of clothing to
prevent Lyme disease.
Clinical Details
Official title: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of Lyme disease
Detailed description:
This is a double-blind, randomized clinical trial using permethrin treatment of clothing to
prevent Lyme disease.
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.
Eligibility
Minimum age: 14 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Summer camp staff at Tomahawk Scout Reservation
- Works in an outdoor environment
- Sleeps in an outdoor environment (platform tent)
- Present for the entire camp season (June - August)
- Informed consent
Exclusion Criteria:
- Contraindication, allergy or previous reaction to permethrin
- Inability of subject or surrogate (e. g., parent if < 18 years of age) to provide
informed consent
Locations and Contacts
Tomahawk Scout Camp, Rice Lake, Wisconsin, United States
Additional Information
Starting date: June 2008
Last updated: July 9, 2012
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