Clinical Trial: Doxycycline in Therapy of Erythema Migrans
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: University Medical Centre Ljubljana
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: University Medical Centre Ljubljana
Dates:
Date Received: November 16, 2011
Date Started: May 2011
Date Completion:
Last Updated: March 23, 2016
Last Verified: March 2016