Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
ConditionErythema Migrans
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana
About this trial
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
erythema migrans
Disqualifiers
pregnancy
extracutaneous manifestations of Lyme borreliosis
immunocompromising state
serious adverse event to beta lactam antibiotic
Trial design
Design model
Parallel
Treatments tested in this trial
EM-amoxicillin 3 x 10 days
DrugPatients will receive amoxicillin 500 milligram tid for 10 days
EM-amoxicillin 3 x 14 days
DrugPatients will receive amoxicillin 500 milligram tid for 14 days
Controls
Other interventionNo intervention.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: EM-amoxicillin 3 x 10 daysActive comparator 1 intervention
Group B: EM-amoxicillin 3 x 14 daysActive comparator 1 intervention
Group C: ControlsOther 1 intervention
Trial outcomes
Primary outcomes
1
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
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.
Time frame
One year follow-upSecondary outcomes
1
Number (frequency) of patients with nonspecific symptoms
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.
Time frame
One year follow-upSponsors and contacts
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University Medical Centre Ljubljana
Lead sponsor
University of Ljubljana School of Medicine, Slovenia
Collaborator
Source ClinicalTrials.gov