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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Erythema Chronicum Migrans
Interventions: Drug: doxycycline
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients older than 15 years evaluated between June and October 2009 at the Lyme Borreliosis Outpatient Clinic, University Medical Center Ljubljana, Slovenia were eligible for the study if they had typical solitary erythema migrans as defined by CDC.

Patients were asked to refer a spouse/friend of the same age ± 5 years to serve as a control.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
241 were evaluated for enrollment and not enrolled in the study.

Reporting Groups
EM-10 Days Doxycycline doxycycline 100 mg b.i.d. for 10 days
EM-doxycycline 15 Days doxycycline 100 b.i.d. for 15 days
Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point

Participant Flow:   Overall Study
    EM-10 Days Doxycycline   EM-doxycycline 15 Days   Controls
STARTED   108   117   81 
COMPLETED   86   91   81 
NOT COMPLETED   22   26   0 
Lost to Follow-up                22                26                0 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr.Dasa Stupica
Organization: UMC Ljubljana, Department of Infectious Diseases
phone: +386 1 522 2110

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Franc Strle, University Medical Centre Ljubljana Identifier: NCT00910715     History of Changes
Other Study ID Numbers: EM-0509
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: October 5, 2011
Results First Posted: July 18, 2012
Last Update Posted: June 2, 2017