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After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permethrin treatment of clothing | Experimental | 0.5% permethrin sprayed one time on uniform shorts, pants, and socks |
|
| Placebo | Sham Comparator | Water sprayed on uniform shorts, pants, and socks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permethrin | Other | Permethrin 0.5% treatment of clothing one time |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Lyme disease | Day <=70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Boulware, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tomahawk Scout Camp | Rice Lake | Wisconsin | United States |
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| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| Placebo |
| Other |
water sprayed on clothing one time |
|
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |