Design Retreatment Study

The Lyme Disease Retreatment Study is designed to evaluate the safety and efficacy of oral antibiotics for retreatment of Lyme disease. This clinical trial evaluates a previous clinical trial showing that retreatment with antibiotics was not effective.

Design:

The study will randomize 108 Lyme disease patients with positive blood tests and 108 Lyme disease patients with negative blood tests to either amoxicillin or placebo. Patients will be treated for up to 3 months.

Target Group of Patients:

• 18 years or older
• Lyme disease symptomatology
• Patients previously successfully treated

Medications:

• Medications provided at no cost for duration of study
• Treatment for at least 3 months:
• All patients will be treated up to 3 months
• Patients are seen at 4 week intervals for 3 visits and then every 6 months

Data Collection:

• 2 simple data forms: Review of symptoms and Patient Impact Form
• Completion time ~20 min for enrollment visit, ~10 min for follow-up visits

Regulatory Requirements:

• Approval by Western IRB

• Signed contract