Clinical Trial: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

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 Summary:

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.

Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Incidence of Lyme disease [ Time Frame: Day <=70 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: August 12, 2009
Date Started: June 2008
Date Completion:
Last Updated: July 9, 2012
Last Verified: July 2012