Phase II, randomised, single-center, open-label study of the efficacy of Ketek® in the treatment of Lyme disease

INTERVENTION: Ketek® versus Amoxicillin (comparator) CONDITION: Lyme disease (LD) ; Infections and Infestations ; Lyme disease PRIMARY OUTCOME: Success using clinical impression SECONDARY OUTCOME: 1. Short Form health survey (SF‐36) ; 2. Review Of Symptoms Scale (ROSS) INCLUSION CRITERIA: 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