Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 3:21 AM
Study NCT ID:
NCT00910533
Status:
UNKNOWN
Last Update Posted:
2018-10-16
First Post:
2009-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Early Lyme Neuroborreliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020852', 'term': 'Lyme Neuroborreliosis'}], 'ancestors': [{'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002443', 'term': 'Ceftriaxone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis', 'timeFrame': '1 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis', 'timeFrame': '1 year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lyme neuroborreliosis'], 'conditions': ['Nervous System Lyme Borreliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* erythema migrans within 4 months before neurologic involvement and pleocytosis in patients \\>15 years old\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* history of adverse reaction to a beta-lactam antibiotic'}, 'identificationModule': {'nctId': 'NCT00910533', 'briefTitle': 'Study on Early Lyme Neuroborreliosis', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis', 'orgStudyIdInfo': {'id': 'LNB-0509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Lyme neuroborreliosis patients', 'interventionNames': ['Drug: ceftriaxone']}, {'type': 'NO_INTERVENTION', 'label': 'control subjects', 'description': 'Control subjects without a history of Lyme borreliosis.'}], 'interventions': [{'name': 'ceftriaxone', 'type': 'DRUG', 'description': 'ceftriaxone 2 g od i.v. for 14 days', 'armGroupLabels': ['Early Lyme neuroborreliosis patients']}]}, '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': 'Dasa Stupica, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Katarina Ogrinc, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Petra Bogovic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eva Ruzic-Sabljic, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tjasa Cerar, PhD', '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': '+38615222110'}, {'name': 'Franc Strle, MD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+38615222110'}], 'overallOfficials': [{'name': 'Franc Strle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Ljubljana'}]}, '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'}}}}