Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
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.
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
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Lyme Disease
Intervention
Permethrin, Placebo
Location
Tomahawk Scout Camp
Rice Lake
Wisconsin
United States
Status
Terminated
Source
University of Minnesota - Clinical and Translational Science Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00958139
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:20:03-0400
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Medical and Biotech [MESH] Definitions
Lyme Disease
An infectious disease caused by a spirochete, BORRELIA BURGDORFERI, which is transmitted chiefly by Ixodes dammini (see IXODES) and pacificus ticks in the United States and Ixodes ricinis (see IXODES) in Europe. It is a disease with early and late cutaneous manifestations plus involvement of the nervous system, heart, eye, and joints in variable combinations. The disease was formerly known as Lyme arthritis and first discovered at Old Lyme, Connecticut.
Lyme Disease Vaccines
Vaccines or candidate vaccines used to prevent LYME DISEASE.
Morgellons Disease
An unexplained illness which is characterized by skin manifestations including non-healing lesions, itching, and the appearance of fibers. There appears to be a strong association with LYME DISEASE.
Ixodes
The largest genus of TICKS in the family IXODIDAE, containing over 200 species. Many infest humans and other mammals and several are vectors of diseases such as LYME DISEASE, tick-borne encephalitis (ENCEPHALITIS, TICK-BORNE), and KYASANUR FOREST DISEASE.
Permethrin
A pyrethroid insecticide commonly used in the treatment of LICE INFESTATIONS and SCABIES.
