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 ]

At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.


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