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Trial record 4 of 64 for:    lyme

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):

August 12, 2009
August 13, 2009
July 10, 2012
June 2008
August 2008   (Final data collection date for primary outcome measure)
Incidence of Lyme disease [ Time Frame: Day <=70 ]
Same as current
Complete list of historical versions of study NCT00958139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Lyme Disease
  • Other: Permethrin
    Permethrin 0.5% treatment of clothing one time
  • Other: Placebo
    water sprayed on clothing one time
  • Experimental: Permethrin treatment of clothing
    0.5% permethrin sprayed one time on uniform shorts, pants, and socks
    Intervention: Other: Permethrin
  • Sham Comparator: Placebo
    Water sprayed on uniform shorts, pants, and socks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
61
October 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00958139
0804M3101
No
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: David R. Boulware, MD, MPH University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP