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Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

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ClinicalTrials.gov Identifier: NCT00958139
Recruitment Status : Terminated (After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.)
First Posted : August 13, 2009
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease
Drug Information available for: Permethrin
U.S. FDA Resources

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958139


Locations
United States, Wisconsin
Tomahawk Scout Camp
Rice Lake, Wisconsin, United States
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: David R. Boulware, MD, MPH University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00958139     History of Changes
Other Study ID Numbers: 0804M3101
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
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