Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Lyme Disease Clinical Trial

Official title:

Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958139
• Other study ID #: 0804M3101
• Status: Terminated
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: June 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Other:
• Permethrin
Permethrin 0.5% treatment of clothing one time
• Placebo
water sprayed on clothing one time

Locations

Country	Name	City	State
United States	Tomahawk Scout Camp	Rice Lake	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Lyme disease		Day <=70