Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome

This study has been completed.
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01518192
First received: June 28, 2010
Last updated: December 18, 2011
Last verified: December 2011
Results First Received: June 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Erythema Migrans
Post-Lyme Disease Symptoms
Interventions: Drug: doxycycline
Drug: cefuroxime axetil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients with typical erythema migrans, examined in the period from June to September 2006 at Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

113/398 patients were ineligible due to:

  • receiving antibiotic with known anti-borrelial activity (73)
  • multiple erythema migrans (16)
  • history of Lyme disease (12)
  • immunocompromising condition (4)
  • serious adverse reaction to study drugs (3)
  • pregnancy or lactation (4)
  • erythema migrans accompanied by meningitis (1)

Reporting Groups
  Description
Doxycycline

Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.

At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.

Cefuroxime Axetil

Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.

At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.

Controls patients' family members or friends without a history of Lyme disease

Participant Flow:   Overall Study
    Doxycycline     Cefuroxime Axetil     Controls  
STARTED     145     140     259  
COMPLETED     116     114     224  
NOT COMPLETED     29     26     35  
Lost to Follow-up                 29                 26                 35  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Doxycycline

Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.

Evaluations:

At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture.

Cefuroxime Axetil

Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.

Evaluations:

At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture.

Controls To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
Total Total of all reporting groups

Baseline Measures
    Doxycycline     Cefuroxime Axetil     Controls     Total  
Number of Participants  
[units: participants]
  145     140     259     544  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 17 to 85 )  
  51.5  
  ( 19 to 82 )  
  52  
  ( 15 to 85 )  
  52.5  
  ( 15 to 85 )  
Gender  
[units: participants]
       
Female     84     77     125     286  
Male     61     63     134     258  
Region of Enrollment  
[units: participants]
       
Slovenia     145     140     259     544  



  Outcome Measures
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1.  Primary:   Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days   [ Time Frame: at 14 days post inclusion ]

2.  Primary:   Adverse Events   [ Time Frame: at 14 days ]

3.  Primary:   Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months   [ Time Frame: 2 months ]

4.  Primary:   Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months   [ Time Frame: 6 months ]

5.  Primary:   Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months   [ Time Frame: 12 months ]

6.  Secondary:   New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.   [ Time Frame: 6 months ]

7.  Secondary:   New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.   [ Time Frame: 12 months ]

8.  Secondary:   Selected Subjective Symptoms in Patients and Control Subjects   [ Time Frame: Examination at 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Medical explanation besides Lyme disease of the symptoms in patients was based on history and physical examination, therefore some other medical explanations might have been missed. With regard to controls this was even more likely.


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


Results Point of Contact:  
Name/Title: Franc Strle
Organization: Department of Infectious Diseases, University Medical Center Ljubljana
phone: +386 1 522 2610
e-mail: franc.strle@kclj.si


No publications provided


Responsible Party: Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01518192     History of Changes
Other Study ID Numbers: EM-DC
Study First Received: June 28, 2010
Results First Received: June 28, 2010
Last Updated: December 18, 2011
Health Authority: Slovenia: Ethics Committee