Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- University of Minnesota
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Incidence of Lyme disease
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Incidence of Lyme disease
Time Frame: Day <=70
Secondary Outcomes
No secondary outcomes reported