Trial record 5 of 30 for:    "Lyme Disease"

Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

This study has been terminated.
(After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period.)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00958139
First received: August 12, 2009
Last updated: July 9, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958139

Locations
United States, Wisconsin
Tomahawk Scout Camp
Rice Lake, Wisconsin, United States
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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 July 24, 2014