Recurrent Lyme disease Infections and Infestations Recurrent Lyme disease
Conditions
Interventions
Amoxicillin versus placebo
Sponsors
Lyme Disease Practice and Research (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or older to include the elderly 2. Both sexes 3. Outpatients 4. A signed consent must be obtained 5. Diagnostic criteria: Lyme disease symptomology as described by Logigian et al
Exclusion criteria
Exclusion criteria: 1. Signs: erythema migrans or physical sign (arthritis, Bell?s palsy, heart block, or meningitis) require treatment and therefore cannot be placed into a placebo arm 2. Inadequate initial treatment: patients not previously treated with at least 21 consecutive days with an antibiotic known to be effective for Lyme disease 3. Patients without any clinical evidence of Lyme disease 4. Patients anticipated to not able to return for follow-up examination 5. Patients with a type 1 hypersensitivity to penicillins 6. Pregnancy and postpartum or lactating female who is nursing 7. Other antibiotics: anticipated requirement of systemic antibiotics other than the study medication 8. Initial treatment failure: patients cannot be enrolled in the re-treatment subgroup if failing the first treatment 9. Medication failure: patients cannot be enrolled if they have a history of failing study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short form 36 (SF-36) 2. Review of symptom severity (ROSS) | — |
Countries
United States of America
Outcome results
None listed