Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT00942006
Status:
UNKNOWN
Last Update Posted:
2009-07-20
First Post:
2009-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020852', 'term': 'Lyme Neuroborreliosis'}, {'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D005929', 'term': 'Glossitis, Benign Migratory'}], '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': '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'}, {'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': 'D002443', 'term': 'Ceftriaxone'}], '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'}, {'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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-17', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.', 'timeFrame': '1 year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lyme neuroborreliosis', 'Lyme borreliosis', 'erythema migrans', 'doxycycline treatment', 'ceftriaxone treatment', 'outcome', 'subjective symptoms'], 'conditions': ['Suspected Early Lyme Neuroborreliosis']}, 'descriptionModule': {'briefSummary': 'The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>15 years\n* erythema migrans in 4 months period before neurologic symptoms\n* normal CSF cell count\n* absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* allergy on doxycycline and ceftriaxone\n* immune deficiency.'}, 'identificationModule': {'nctId': 'NCT00942006', 'briefTitle': 'Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.', 'orgStudyIdInfo': {'id': 'LNB-doxy-ceftriaxone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LNB-doxycycline', 'interventionNames': ['Drug: doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LNB-ceftriaxone', 'interventionNames': ['Drug: ceftriaxone']}], 'interventions': [{'name': 'doxycycline', 'type': 'DRUG', 'description': '100 mg bid, 14 days', 'armGroupLabels': ['LNB-doxycycline']}, {'name': 'ceftriaxone', 'type': 'DRUG', 'description': '2g x 1 iv, 14 days', 'armGroupLabels': ['LNB-ceftriaxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1525', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'UMC Ljubljana, Department of Infectious Diseases', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Katarina Ogrinc, MD PhD', 'role': 'CONTACT', 'email': 'katarina.ogrinc1@guest.arnes.si', 'phone': '+386 1 522 4217'}, {'name': 'Franc Strle, PhD MD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 522 2110'}], 'overallOfficials': [{'name': 'Franc Strle, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Katarina Ogrinc MD PhD', 'oldOrganization': 'UMC Ljubljana'}}}}