Duration of Antibiotic Treatment of Erythema Migrans
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|ClinicalTrials.gov Identifier: NCT00910715|
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : July 18, 2012
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Erythema Chronicum Migrans||Drug: doxycycline Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Active Comparator: EM-10 days doxycycline||
doxycycline 100 mg bid, 10 days
|Active Comparator: EM-doxycycline 15 days||
doxycycline 100 mg bid, 15 days
|Placebo Comparator: controls||
control subjects without a history of Lyme borreliosis
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910715
|UMC Ljubljana, Department of Infectious Diseases|
|Ljubljana, Slovenia, 1525|
|Study Chair:||Franc Strle, MD||UMC Ljubljana|