Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 11:00 AM
Study NCT ID:
NCT01163994
Status:
UNKNOWN
Last Update Posted:
2017-05-05
First Post:
2010-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment of Multiple Erythema Migrans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-18', 'releaseDate': '2018-05-03'}, {'resetDate': '2019-06-03', 'releaseDate': '2019-04-19'}], 'estimatedResultsFirstSubmitDate': '2018-05-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005929', 'term': 'Glossitis, Benign Migratory'}, {'id': 'D008193', 'term': 'Lyme Disease'}], 'ancestors': [{'id': 'D005928', 'term': 'Glossitis'}, {'id': 'D014060', 'term': 'Tongue Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.', 'timeFrame': 'enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.', 'timeFrame': 'second assessment at 14 days postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.', 'timeFrame': 'third assessment at 2 months postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.', 'timeFrame': 'fourth assessment at 6 months postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.', 'timeFrame': 'fifth assessment at 12 months postenrollment'}], 'secondaryOutcomes': [{'measure': 'Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.', 'timeFrame': 'enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.', 'timeFrame': 'enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter'}, {'measure': 'Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.', 'timeFrame': 'second assessment at 6 months postenrollment'}, {'measure': 'Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.', 'timeFrame': 'third assessment at 6 months postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.', 'timeFrame': 'second assessment at 14 days postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.', 'timeFrame': 'third assessment at 2 months postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.', 'timeFrame': 'fourth assessment at 6 months postenrollment'}, {'measure': 'Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.', 'timeFrame': 'fifth assessment at 12 months postenrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['erythema migrans', 'Lyme borreliosis', 'ceftriaxone treatment', 'doxycycline treatment', 'outcome', 'subjective symptoms'], 'conditions': ['Multiple Erythema Migrans']}, 'referencesModule': {'references': [{'pmid': '30075748', 'type': 'DERIVED', '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.'}, {'pmid': '29385444', 'type': 'DERIVED', 'citation': 'Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiple erythema migrans in patients \\> 15 years\n\nExclusion Criteria:\n\n* a history of Lyme borreliosis in the past\n* pregnancy or lactation\n* immunocompromised status\n* serious adverse event to doxycycline or beta lactam antibiotic\n* taking antibiotic with antiborrelial activity within 10 days'}, 'identificationModule': {'nctId': 'NCT01163994', 'briefTitle': 'Antibiotic Treatment of Multiple Erythema Migrans', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans', 'orgStudyIdInfo': {'id': 'MEM-0510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MEM-ceftriaxone', 'interventionNames': ['Drug: ceftriaxone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MEM-doxycycline', 'interventionNames': ['Drug: doxycycline']}, {'type': 'NO_INTERVENTION', 'label': 'controls'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EM-doxycycline', 'interventionNames': ['Other: erythema migrans patients treated with doxycycline']}], 'interventions': [{'name': 'ceftriaxone', 'type': 'DRUG', 'description': 'intravenously, 2 g, qd, 15 days', 'armGroupLabels': ['MEM-ceftriaxone']}, {'name': 'doxycycline', 'type': 'DRUG', 'description': 'orally, 100 mg, bid, 15 days', 'armGroupLabels': ['MEM-doxycycline']}, {'name': 'erythema migrans patients treated with doxycycline', 'type': 'OTHER', 'description': 'orally, 100 mg, bid, 15 days', 'armGroupLabels': ['EM-doxycycline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1525', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Dasa Stupica, MD', 'role': 'CONTACT', 'email': 'cerar.dasa@gmail.com', 'phone': '+386 1 522 2110'}, {'name': 'Franc Strle, MD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 5222610'}, {'name': 'Petra Bogovic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katarina Ogrinc, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eva Ruzic-Sabljic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tjasa Cerar, Dipl Microbiol', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UMC Ljubljana, Department of Infectious Diseases', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Dasa Stupica, MD', 'role': 'CONTACT', 'email': 'cerar.dasa@gmail.com', 'phone': '+386 1 522 2110'}, {'name': 'Franc Strle, MD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 522 2610'}], 'overallOfficials': [{'name': 'Franc Strle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Ljubljana'}, {'name': 'Dasa Stupica, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD', 'investigatorFullName': 'Franc Strle', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-05-03', 'type': 'RELEASE'}, {'date': '2018-10-18', 'type': 'RESET'}, {'date': '2019-04-19', 'type': 'RELEASE'}, {'date': '2019-06-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Franc Strle, M.D., PhD, University Medical Centre Ljubljana'}}}}