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

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total Total of all reporting groups

Baseline Measures
   EM-10 Days Doxycycline   EM-doxycycline 15 Days   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   117   0   225 
[Units: Participants]
Count of Participants
<=18 years      2   1.9%      2   1.7%         4   1.8% 
Between 18 and 65 years      88  81.5%      101  86.3%         189  84.0% 
>=65 years      18  16.7%      14  12.0%         32  14.2% 
[Units: Years]
Mean (Standard Deviation)
 52.5  (14.3)   49.6  (14.0)      50.4  (14.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      62  57.4%      63  53.8%         125  55.6% 
Male      46  42.6%      54  46.2%         100  44.4% 
Region of Enrollment 
[Units: Participants]
Slovenia   108   117      225 

  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