Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 510
- Locations
- 1
- Primary Endpoint
- Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
Study Overview
Brief Summary
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •erythema migrans
Exclusion Criteria
- •pregnancy
- •extracutaneous manifestations of Lyme borreliosis
- •immunocompromising state
- •serious adverse event to beta lactam antibiotic
- •receiving antibiotic with antiborrelial activity within 10 days
Arms & Interventions
EM-amoxicillin 3 x 10 days
Intervention: EM-amoxicillin 3 x 10 days (Drug)
EM-amoxicillin 3 x 14 days
Intervention: EM-amoxicillin 3 x 14 days (Drug)
EM-amoxicillin 2 x 14 days
Intervention: EM-amoxicillin 2 x 14 days (Drug)
Controls
Intervention: Controls (Other)
Outcomes
Primary Outcomes
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
Time Frame: One year follow-up
At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.
Secondary Outcomes
- Number (frequency) of patients with nonspecific symptoms(One year follow-up)
Investigators
Daša Stupica
Principal Investigator
University Medical Centre Ljubljana