Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Phase 3

Terminated

• Conditions: Lyme Disease
• Interventions: Other: Permethrin; Other: Placebo

• Registration Number: NCT00958139
• Lead Sponsor: University of Minnesota

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2008-08
• Study Completion: 2008-10
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Permethrin treatment of clothing	Permethrin	0.5% permethrin sprayed one time on uniform shorts, pants, and socks
Placebo	Placebo	Water sprayed on uniform shorts, pants, and socks

Primary Outcome Measures

Name	Time	Method
Incidence of Lyme disease	Day <=70

Trial Locations

Locations (1)

Tomahawk Scout Camp; 🇺🇸 Rice Lake, Wisconsin, United States