Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04653558
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2020-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D020852', 'term': 'Lyme Neuroborreliosis'}], 'ancestors': [{'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'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2020-11-28', 'studyFirstSubmitQcDate': '2020-11-28', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite clinical score', 'timeFrame': 'follow-up for 12 months-post-treatment', 'description': 'Composite clinical score based on objective clinical findings and subjective complaints. The sum of subjective complaints and objective findings scored as 0=absent or 1=present represent severity of disease on admission or clinical outcome at follow-up, respectively. Maximum total score=31'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lyme neuroborreliosis', 'post-Lyme borreliosis symptoms', 'antibiotic therapy'], 'conditions': ['Lyme Disease']}, 'descriptionModule': {'briefSummary': 'In this retrospective cohort study of patients with early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with definite or possible early Lyme neuroborreliosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* early Lyme neuroborreliosis\n\nExclusion Criteria:\n\n* Not fulfilling study criteria for definite or possible Lyme neuroborreliosis\n* Alternative diagnosis during follow-up\n* Concomitant tick-borne encephalitis\n* Clinical symptoms/signs present for \\>6 months\n* Data not available'}, 'identificationModule': {'nctId': 'NCT04653558', 'briefTitle': 'Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis According to Diagnostic Certainty', 'orgStudyIdInfo': {'id': 'LNB-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'definite LNB', 'description': 'patients with definite early Lyme neuroborreliosis'}, {'label': 'possible LNB', 'description': 'patients with possible early Lyme neuroborreliosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Only on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daša Stupica', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}