Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-02 @ 2:31 AM
Study NCT ID:
NCT01518192
Status:
COMPLETED
Last Update Posted:
2012-01-25
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005929', 'term': 'Glossitis, Benign Migratory'}], 'ancestors': [{'id': 'D005928', 'term': 'Glossitis'}, {'id': 'D014060', 'term': 'Tongue Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'C040738', 'term': 'cefuroxime axetil'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'franc.strle@kclj.si', 'phone': '+386 1 522 2610', 'title': 'Franc Strle', 'organization': 'Department of Infectious Diseases, University Medical Center Ljubljana'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Doxycycline', 'description': 'Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.\n\nAt 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.', 'otherNumAtRisk': 145, 'otherNumAffected': 21, 'seriousNumAtRisk': 145, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cefuroxime Axetil', 'description': 'Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.\n\nAt 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.', 'otherNumAtRisk': 140, 'otherNumAffected': 21, 'seriousNumAtRisk': 140, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Controls', 'description': "patients' family members or friends without a history of Lyme disease", 'otherNumAtRisk': 259, 'otherNumAffected': 0, 'seriousNumAtRisk': 259, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.7'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'doxycycline 100 mg twice daily for 15 days'}, {'id': 'OG001', 'title': 'Cefuroxime Axetil', 'description': 'cefuroxime axetil 500 mg twice daily for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 14 days post inclusion', 'description': 'Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who followed the protocol were eligible for analysis'}, {'type': 'SECONDARY', 'title': 'New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients', 'description': 'patients with new or increased symptoms since erythema migrans at 6 months post inclusion'}, {'id': 'OG001', 'title': 'Controls', 'description': 'controls with new or increased symptoms since enrollment at 6 months post inclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}, {'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'doxycycline 100 mg twice daily for 15 days'}, {'id': 'OG001', 'title': 'Cefuroxime Axetil', 'description': 'cefuroxime axetil 500 mg twice daily for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 14 days', 'description': 'Number of patients reporting adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who followed the protocol.'}, {'type': 'PRIMARY', 'title': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'doxycycline 100 mg twice daily for 15 days'}, {'id': 'OG001', 'title': 'Cefuroxime Axetil', 'description': 'cefuroxime axetil 500 mg twice daily for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}, {'type': 'PRIMARY', 'title': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'doxycycline 100 mg twice daily for 15 days'}, {'id': 'OG001', 'title': 'Cefuroximew Axetil', 'description': 'cefuroxime axetil 500 mg twice daily for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}, {'type': 'PRIMARY', 'title': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'doxycycline 100 mg twice daily for 15 days'}, {'id': 'OG001', 'title': 'Cefuroxime Axetil', 'description': 'cefuroxime axetil 500 mg twice daily for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}, {'type': 'SECONDARY', 'title': 'New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients', 'description': 'patients with new or increased symptoms since erythema migrans at 12 months post inclusion'}, {'id': 'OG001', 'title': 'Controls', 'description': 'controls with new or increased symptoms since erythema migrans at 12 months post inclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}, {'type': 'SECONDARY', 'title': 'Selected Subjective Symptoms in Patients and Control Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients', 'description': 'patients with selected subjective symptoms at 12 months post inclusion'}, {'id': 'OG001', 'title': 'Controls', 'description': 'controls with selected subjective symptoms at 12 months post inclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Examination at 12 months', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who followed the protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxycycline', 'description': 'Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.\n\nAt 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.'}, {'id': 'FG001', 'title': 'Cefuroxime Axetil', 'description': 'Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.\n\nAt 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.'}, {'id': 'FG002', 'title': 'Controls', 'description': "patients' family members or friends without a history of Lyme disease"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '259'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '224'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '35'}]}]}], 'recruitmentDetails': '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', 'preAssignmentDetails': '113/398 patients were ineligible due to:\n\n* receiving antibiotic with known anti-borrelial activity (73)\n* multiple erythema migrans (16)\n* history of Lyme disease (12)\n* immunocompromising condition (4)\n* serious adverse reaction to study drugs (3)\n* pregnancy or lactation (4)\n* erythema migrans accompanied by meningitis (1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}, {'value': '544', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxycycline', '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.\n\nEvaluations:\n\nAt 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.'}, {'id': 'BG001', 'title': 'Cefuroxime Axetil', '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.\n\nEvaluations:\n\nAt 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.'}, {'id': 'BG002', 'title': 'Controls', 'description': '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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '14.6', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '85'}, {'value': '51.5', 'spread': '14.9', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '82'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '85'}, {'value': '52.5', 'spread': '14.9', 'groupId': 'BG003', 'lowerLimit': '15', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '286.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '258.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Slovenia', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}, {'value': '544.0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-18', 'studyFirstSubmitDate': '2010-06-28', 'resultsFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2011-12-18', 'lastUpdatePostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-18', 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days', 'timeFrame': 'at 14 days post inclusion', 'description': 'Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion'}, {'measure': 'Adverse Events', 'timeFrame': 'at 14 days', 'description': 'Number of patients reporting adverse events'}, {'measure': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months', 'timeFrame': '2 months', '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'}, {'measure': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months', 'timeFrame': '6 months', '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'}, {'measure': 'Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months', 'timeFrame': '12 months', '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'}], 'secondaryOutcomes': [{'measure': 'New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.', 'timeFrame': '6 months', 'description': 'Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.'}, {'measure': 'New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.', 'timeFrame': '12 months', 'description': 'Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.'}, {'measure': 'Selected Subjective Symptoms in Patients and Control Subjects', 'timeFrame': 'Examination at 12 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['erythema migrans', 'doxycycline', 'cefuroxime axetil', 'post-Lyme disease symptoms', 'background symptoms in general population'], 'conditions': ['Erythema Migrans', 'Post-Lyme Disease Symptoms']}, 'descriptionModule': {'briefSummary': 'Background:\n\n* While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii.\n* Controversy exists over the significance and even the existence of post-Lyme disease symptoms because of the high rate of similar background symptoms in the general population.\n\nPurpose:\n\nThe two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are:\n\n* To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and\n* to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.', 'detailedDescription': 'Sample size\n\nDecisions were based on the following:\n\n1. Number of patients with erythema migrans treated with doxycycline and cefuroxime axetil was determined assuming no difference in treatment outcome will be detected (non-inferiority testing).\n2. The decision for a larger sample sizes than needed for 1. was done with the intention to evaluate the secondary outcome measure, i.e., to assess the difference between the frequency of new or increased symptoms in patients treated for early Lyme disease and the occurrence of the same symptoms in control subjects.\n\n 1. We assumed that the outcomes in the two treatment groups will be comparable and that the patients could be combined for further analysis.\n 2. To obtain a control group from the same geographical area, each patient was asked if she or he had a family member or friend who was within 5 years of her or his age and who was without a history of Lyme borreliosis. These persons were approached by a short written explanation of the investigation, containing also a request for their participation. We assumed that we will be able to get a corresponding control person not for all but for approximately 80-90% of patients.\n 3. Under the assumption that approximately 15% of an estimated 200 patients would have new or increased symptoms at \\>6 months after enrollment into the study, a control group of 165 subjects would be sufficient to detect a \\>10 percentage point lower rate of new or increased symptoms in controls compared with patients at the 0.05 level (2-sided) with \\>90% power. To comply with drop outs at different time points we assessed that 280 patients and 230 controls should be included at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 15 or more years old\n* with typical erythema migrans\n* evaluated between 6/06 and 9/06\n* evaluated at the Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia.\n\nExclusion Criteria:\n\n* history of Lyme disease in the past\n* pregnancy\n* lactation\n* immunocompromising condition\n* history of a serious adverse reaction to a beta-lactam or tetracycline drug\n* receiving an antibiotic with known anti-borrelial activity within 10 days\n* multiple erythema migrans lesions or an extracutaneous manifestation of Lyme disease.'}, 'identificationModule': {'nctId': 'NCT01518192', 'briefTitle': 'Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Risk Factors for Failure of Erythema Migrans Treatment - Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Adult Patients With Erythema Migrans: Clinical and Microbiological Outcome.', 'orgStudyIdInfo': {'id': 'EM-DC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1Doxycycline', 'interventionNames': ['Drug: doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Cefuroxime axetil', 'interventionNames': ['Drug: cefuroxime axetil']}], 'interventions': [{'name': 'doxycycline', 'type': 'DRUG', 'description': '100 mg bid; 15 days', 'armGroupLabels': ['1Doxycycline']}, {'name': 'cefuroxime axetil', 'type': 'DRUG', 'description': '500 mg bid; 15 days', 'armGroupLabels': ['2 Cefuroxime axetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1525', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Daša Cerar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia'}, {'name': 'Franc Strle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Slovenian Research Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD', 'investigatorFullName': 'Franc Strle', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}