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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 : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 12, 2009
First Posted Date  ICMJE August 13, 2009
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
Incidence of Lyme disease [ Time Frame: Day <=70 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Official Title  ICMJE Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lyme Disease
Intervention  ICMJE
  • Other: Permethrin
    Permethrin 0.5% treatment of clothing one time
  • Other: Placebo
    water sprayed on clothing one time
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2009)
61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00958139
Other Study ID Numbers  ICMJE 0804M3101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R. Boulware, MD, MPH University of Minnesota
PRS Account University of Minnesota
Verification Date June 2020

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