An observational study in Lyme Borreliosis, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-24.
Sponsored by University Medical Centre Ljubljana · Observational
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.
Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.
Exclusion Criteria:
patients with erythema migrans and no additional newly onset symptoms treated with doxycycline
Drug: Doxycycline
patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline
Drug: Doxycycline
patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline
Drug: Doxycycline
100 mg PO bid, 14 days
Also known as: Doxy
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
Time frame: 1 year follow-up
Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
Time frame: 1 year follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Borrelia Infections
University Medical Centre Ljubljana