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Duration of Antibiotic Treatment of Erythema Migrans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910715
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : July 18, 2012
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Erythema Chronicum Migrans Drug: doxycycline Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: EM-10 days doxycycline Drug: doxycycline
doxycycline 100 mg bid, 10 days

Active Comparator: EM-doxycycline 15 days Drug: doxycycline
doxycycline 100 mg bid, 15 days

Placebo Comparator: controls Drug: placebo
control subjects without a history of Lyme borreliosis

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • solitary erythema migrans in patients > 15 years

Exclusion Criteria:

  • a history of Lyme borreliosis in the past
  • pregnancy or lactation
  • immunocompromised status
  • serious adverse event to doxycycline
  • taking antibiotic with antiborrelial activity within 10 days
  • multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00910715

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UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
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Study Chair: Franc Strle, MD UMC Ljubljana
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana Identifier: NCT00910715    
Other Study ID Numbers: EM-0509
First Posted: June 1, 2009    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: June 2, 2017
Last Verified: May 2017
Keywords provided by Franc Strle, University Medical Centre Ljubljana:
erythema migrans
Lyme borreliosis
doxycycline treatment
subjective symptoms
Additional relevant MeSH terms:
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Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Skin Manifestations
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents