Clinical Trial: Duration of Antibiotic Treatment of Erythema Migrans
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
Brief Summary: The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
Detailed Summary:
Sponsor: University Medical Centre Ljubljana
Current Primary Outcome: Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. [ Time Frame: 1 year follow-up ]
Original Primary Outcome: Objective sequelae and post-treatment subjective symptoms in patients treated for erythema migrans with doxycycline for 10 or 15 days. [ Time Frame: 1 year follow-up ]
Current Secondary Outcome: Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms. [ Time Frame: 6 months after treatment ]
6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.
For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).
Original Secondary Outcome: Comparison of subjective symptoms between patients treated with doxycycline for 10 or 15 days for erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ]
Information By: University Medical Centre Ljubljana
Dates:
Date Received: May 28, 2009
Date Started: June 2009
Date Completion:
Last Updated: May 28, 2015
Last Verified: May 2015