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

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ClinicalTrials.gov Identifier: NCT01518192
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : January 25, 2012
Last Update Posted : January 25, 2012
Sponsor:
Collaborator:
Slovenian Research Agency
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: Treatment
Conditions Erythema Migrans
Post-Lyme Disease Symptoms
Interventions Drug: doxycycline
Drug: cefuroxime axetil
Enrollment 544
Recruitment Details 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

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)
Arm/Group Title Doxycycline Cefuroxime Axetil Controls
Hide Arm/Group Description

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.

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.

patients' family members or friends without a history of Lyme disease
Period Title: Overall Study
Started 145 140 259
Completed 116 114 224
Not Completed 29 26 35
Reason Not Completed
Lost to Follow-up             29             26             35
Arm/Group Title Doxycycline Cefuroxime Axetil Controls Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 145 140 259 544
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 145 participants 140 participants 259 participants 544 participants
54
(17 to 85)
51.5
(19 to 82)
52
(15 to 85)
52.5
(15 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 140 participants 259 participants 544 participants
Female
84
  57.9%
77
  55.0%
125
  48.3%
286.0
Male
61
  42.1%
63
  45.0%
134
  51.7%
258.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 145 participants 140 participants 259 participants 544 participants
145 140 259 544
1.Primary Outcome
Title Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days
Time Frame at 14 days post inclusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who followed the protocol were eligible for analysis
Arm/Group Title Doxycycline Cefuroxime Axetil
Hide Arm/Group Description:
doxycycline 100 mg twice daily for 15 days
cefuroxime axetil 500 mg twice daily for 15 days
Overall Number of Participants Analyzed 145 140
Measure Type: Number
Unit of Measure: participants
30 27
2.Primary Outcome
Title Adverse Events
Hide Description Number of patients reporting adverse events
Time Frame at 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who followed the protocol.
Arm/Group Title Doxycycline Cefuroxime Axetil
Hide Arm/Group Description:
doxycycline 100 mg twice daily for 15 days
cefuroxime axetil 500 mg twice daily for 15 days
Overall Number of Participants Analyzed 145 140
Measure Type: Number
Unit of Measure: participants
22 23
3.Primary Outcome
Title Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months
Hide Description Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Doxycycline Cefuroxime Axetil
Hide Arm/Group Description:
doxycycline 100 mg twice daily for 15 days
cefuroxime axetil 500 mg twice daily for 15 days
Overall Number of Participants Analyzed 136 134
Measure Type: Number
Unit of Measure: participants
19 14
4.Primary Outcome
Title Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months
Hide Description Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Doxycycline Cefuroximew Axetil
Hide Arm/Group Description:
doxycycline 100 mg twice daily for 15 days
cefuroxime axetil 500 mg twice daily for 15 days
Overall Number of Participants Analyzed 102 93
Measure Type: Number
Unit of Measure: participants
5 6
5.Primary Outcome
Title Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months
Hide Description Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Doxycycline Cefuroxime Axetil
Hide Arm/Group Description:
doxycycline 100 mg twice daily for 15 days
cefuroxime axetil 500 mg twice daily for 15 days
Overall Number of Participants Analyzed 116 114
Measure Type: Number
Unit of Measure: participants
3 4
6.Secondary Outcome
Title New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.
Hide Description Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Patients Controls
Hide Arm/Group Description:
patients with new or increased symptoms since erythema migrans at 6 months post inclusion
controls with new or increased symptoms since enrollment at 6 months post inclusion
Overall Number of Participants Analyzed 194 236
Measure Type: Number
Unit of Measure: participants
9 16
7.Secondary Outcome
Title New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.
Hide Description Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Patients Controls
Hide Arm/Group Description:
patients with new or increased symptoms since erythema migrans at 12 months post inclusion
controls with new or increased symptoms since erythema migrans at 12 months post inclusion
Overall Number of Participants Analyzed 230 224
Measure Type: Number
Unit of Measure: participants
5 21
8.Secondary Outcome
Title Selected Subjective Symptoms in Patients and Control Subjects
Hide Description Comparison of the number of patients and controls with selected 8 symptoms (fatigue, arthralgias, myalgias, headache, paresthesias, dizziness, irritability, or nausea) within the preceding week, irrespective of whether they were new or increased since erythema migrans.
Time Frame Examination at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants who followed the protocol
Arm/Group Title Patients Controls
Hide Arm/Group Description:
patients with selected subjective symptoms at 12 months post inclusion
controls with selected subjective symptoms at 12 months post inclusion
Overall Number of Participants Analyzed 230 224
Measure Type: Number
Unit of Measure: participants
178 181
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Cefuroxime Axetil Controls
Hide Arm/Group Description

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.

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.

patients' family members or friends without a history of Lyme disease
All-Cause Mortality
Doxycycline Cefuroxime Axetil Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Cefuroxime Axetil Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/145 (0.00%)      0/140 (0.00%)      0/259 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.7%
Doxycycline Cefuroxime Axetil Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/145 (14.48%)      21/140 (15.00%)      0/259 (0.00%)    
Gastrointestinal disorders       
Gastrointestinal symptoms *  20/145 (13.79%)  20 21/140 (15.00%)  21 0/259 (0.00%)  0
General disorders       
Photosensitivity *  1/145 (0.69%)  1 0/140 (0.00%)  0 0/259 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
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
Responsible Party: Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01518192     History of Changes
Other Study ID Numbers: EM-DC
First Submitted: June 28, 2010
First Posted: January 25, 2012
Results First Submitted: June 28, 2010
Results First Posted: January 25, 2012
Last Update Posted: January 25, 2012