Phase II, randomised, single-center, open-label study of the efficacy of Ketek® in the treatment of Lyme disease
- Conditions
- yme disease (LD)Infections and InfestationsLyme disease
- Registration Number
- ISRCTN03563617
- Lead Sponsor
- First Medical Associates (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Patients with clinically suspected recurrent LD evaluated in a primary care setting in a Lyme disease endemic area, will be eligible for participation in the study if they meet the selection criteria:
1. Clinically documented disease described by Asch et al. and Logigian et al.
2. History of previous oral and intravenous antibiotics
3. Age 18 years or older to include the elderly (no upper age limits will be established)
4. Both sexes
5. A written informed consent document regarding the experimental nature of the study
6. Ability to comply with the protocol follow-up
7. Women of childbearing potential must be using a medically acceptable method of birth control and have a negative serum Human Chorionic Gonadotropin (HCG) pregnancy test result at the initial screening visit
Exclusion criteria will be limited to secure inclusion of as many patients as possible, thus avoiding difficulties in generalising the results. Patients will be excluded from the study if:
1. They have not previously been treated for at least 21 days with an antibiotic known to be effective for Lyme disease
2. They are not able to return for follow-up
3. They have a history of allergies to erythromycin, macrolides, or Ketek®
4. They have a history of allergies to both amoxicillin and doxycycline
5. They are pregnant or are a postpartum/lactating female who is nursing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method