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Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Primary Purpose

Lyme Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Permethrin
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lyme Disease focused on measuring Lyme disease, tick

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tomahawk Scout Camp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Permethrin treatment of clothing

Placebo

Arm Description

0.5% permethrin sprayed one time on uniform shorts, pants, and socks

Water sprayed on uniform shorts, pants, and socks

Outcomes

Primary Outcome Measures

Incidence of Lyme disease

Secondary Outcome Measures

Full Information

First Posted
August 12, 2009
Last Updated
June 2, 2020
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00958139
Brief Title
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Official Title
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Lyme disease, tick

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permethrin treatment of clothing
Arm Type
Experimental
Arm Description
0.5% permethrin sprayed one time on uniform shorts, pants, and socks
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Water sprayed on uniform shorts, pants, and socks
Intervention Type
Other
Intervention Name(s)
Permethrin
Intervention Description
Permethrin 0.5% treatment of clothing one time
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
water sprayed on clothing one time
Primary Outcome Measure Information:
Title
Incidence of Lyme disease
Time Frame
Day <=70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Boulware, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomahawk Scout Camp
City
Rice Lake
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

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