Study Stopped
After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedJune 4, 2020
June 1, 2020
2 months
August 12, 2009
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Lyme disease
Day <=70
Study Arms (2)
Permethrin treatment of clothing
EXPERIMENTAL0.5% permethrin sprayed one time on uniform shorts, pants, and socks
Placebo
SHAM COMPARATORWater sprayed on uniform shorts, pants, and socks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication, allergy or previous reaction to permethrin
- Inability of subject or surrogate (e.g., parent if \< 18 years of age) to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tomahawk Scout Camp
Rice Lake, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Boulware, MD, MPH
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
June 1, 2008
Primary Completion
August 1, 2008
Study Completion
October 1, 2008
Last Updated
June 4, 2020
Record last verified: 2020-06