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.
97 studies on the registry are indexed under Lyme Disease; 26 are open to participants now.
This study's enrollment of 400 is close to the median of 400 across 42 observational studies indexed under Lyme Disease.
Browse Lyme Disease studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The record gives a start of May 2011, a primary completion of Oct 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.
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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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