Single-investigator, randomized, double-blind, placebo-controlled trial of the efficacy and safety of oral antibiotics versus placebo in recurrent seropositive and seronegative Lyme disease

Completed

• Conditions: Recurrent Lyme disease; Infections and Infestations

• Registration Number: ISRCTN19325889
• Lead Sponsor: yme Disease Practice and Research (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified