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Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lyme Disease

Intervention: Permethrin (Other); Placebo (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
David R. Boulware, MD, MPH, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of 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.

Eligibility

Minimum age: 14 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Tomahawk Scout Camp, Rice Lake, Wisconsin, United States
Additional Information

Starting date: June 2008
Last updated: July 9, 2012

Page last updated: August 23, 2015

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