Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

• ClinicalTrials.gov Identifier: NCT00958139
• Recruitment Status: Terminated
• First Posted: August 13, 2009
• Last Update Posted: June 4, 2020
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lyme Disease	Other: Permethrin; Other: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
• Study Start Date: June 2008
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Permethrin treatment of clothing; 0.5% permethrin sprayed one time on uniform shorts, pants, and socks	Other: Permethrin; Permethrin 0.5% treatment of clothing one time
Sham Comparator: Placebo; Water sprayed on uniform shorts, pants, and socks	Other: Placebo; water sprayed on clothing one time

Outcome Measures

Primary Outcome Measures :

1. Incidence of Lyme disease [ Time Frame: Day <=70 ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Wisconsin

Tomahawk Scout Camp

Rice Lake, Wisconsin, United States

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: David R. Boulware, MD, MPH; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00958139
• Other Study ID Numbers: 0804M3101
• First Posted: August 13, 2009
• Last Update Posted: June 4, 2020
• Last Verified: June 2020

Keywords provided by University of Minnesota:

Lyme disease; tick

Additional relevant MeSH terms:

Lyme Disease; Borrelia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Tick-Borne Diseases; Spirochaetales Infections; Permethrin; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action