Multiple Erythema Migrans
Conditions
Keywords
erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms
Brief summary
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.
Interventions
DRUGceftriaxone
intravenously, 2 g, qd, 15 days
DRUGdoxycycline
orally, 100 mg, bid, 15 days
OTHERerythema migrans patients treated with doxycycline
orally, 100 mg, bid, 15 days
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* multiple erythema migrans in patients \> 15 years
Exclusion criteria
* a history of Lyme borreliosis in the past * pregnancy or lactation * immunocompromised status * serious adverse event to doxycycline or beta lactam antibiotic * taking antibiotic with antiborrelial activity within 10 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. | enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. | enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter |
Countries
Slovenia
Contacts
Primary ContactDasa Stupica, MD
Backup ContactFranc Strle, MD
Outcome results
None listed