Back to resultsComparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans
Primary Purpose
Erythema Chronicum Migrans
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
doxycycline
Cefuroxime Axetil 500Mg Tab
control subjects
Sponsored by
About this trial
This is an interventional treatment trial for Erythema Chronicum Migrans
Eligibility Criteria
Inclusion Criteria:
- typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion <5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.
Exclusion Criteria:
- Lyme disease previously
- pregnancy or lactation
- immunocompromised
- serious adverse reaction to a beta-lactam or tetracycline drug in the past
- received an antibiotic with known anti-borrelial activity within 10 days
- multiple erythema migrans lesions
- presence of an extracutaneous manifestation of Lyme disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
EM doxycycline
EM cefuroxime axetil
controls
Arm Description
patients with EM who received doxycycline
patients with EM who received cefuroxime axetil
control subjects without history of Lyme disease
Outcomes
Primary Outcome Measures
Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days
At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.
Secondary Outcome Measures
Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, 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).
Full Information
NCT ID
NCT03584919
First Posted
June 19, 2018
Last Updated
July 11, 2018
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03584919
Brief Title
Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans
Official Title
Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2006 (Actual)
Primary Completion Date
September 30, 2007 (Actual)
Study Completion Date
September 30, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Chronicum Migrans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
509 (false)
8. Arms, Groups, and Interventions
Arm Title
EM doxycycline
Arm Type
Active Comparator
Arm Description
patients with EM who received doxycycline
Arm Title
EM cefuroxime axetil
Arm Type
Active Comparator
Arm Description
patients with EM who received cefuroxime axetil
Arm Title
controls
Arm Type
Placebo Comparator
Arm Description
control subjects without history of Lyme disease
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
patients received oral doxycycline 100 milgrams bid for 15 days
Intervention Type
Drug
Intervention Name(s)
Cefuroxime Axetil 500Mg Tab
Intervention Description
patients received cefuroxime axetil 500 milgrams bid for 15 days
Intervention Type
Other
Intervention Name(s)
control subjects
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days
Description
At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.
Time Frame
One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)
Secondary Outcome Measure Information:
Title
Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
Description
12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, 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).
Time Frame
12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion <5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.
Exclusion Criteria:
Lyme disease previously
pregnancy or lactation
immunocompromised
serious adverse reaction to a beta-lactam or tetracycline drug in the past
received an antibiotic with known anti-borrelial activity within 10 days
multiple erythema migrans lesions
presence of an extracutaneous manifestation of Lyme disease
12. IPD Sharing Statement
Citations:
PubMed Identifier
30075748
Citation
Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
Results Reference
derived
Learn more about this trial
Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans
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