Erythema Migrans
Conditions
Brief summary
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Interventions
DRUGEM-amoxicillin 3 x 10 days
Patients will receive amoxicillin 500 milligram tid for 10 days
DRUGEM-amoxicillin 3 x 14 days
Patients will receive amoxicillin 500 milligram tid for 14 days
OTHERControls
No intervention.
Sponsors
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Number (frequency) of patients with nonspecific symptoms | One year follow-up | At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week. |
Countries
Slovenia
Contacts
CONTACTDaša Stupica, MD PhD
CONTACTMaša Velušček, MD
PRINCIPAL_INVESTIGATORDaša Stupica, MD PhD
Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
Outcome results
None listed