Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lyme Disease |
Other: Permethrin Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes |
- Incidence of Lyme disease [ Time Frame: Day <=70 ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 14 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Wisconsin | |
| Tomahawk Scout Camp | |
| Rice Lake, Wisconsin, United States | |
| Principal Investigator: | David R. Boulware, MD, MPH | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00958139 History of Changes |
| Other Study ID Numbers: | 0804M3101 |
| Study First Received: | August 12, 2009 |
| Last Updated: | July 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013