Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
61 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal