Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-04 @ 8:07 PM
Study NCT ID:
NCT02328469
Status:
UNKNOWN
Last Update Posted:
2018-05-04
First Post:
2014-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aseptic Meningoencephalitis in Slovenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008582', 'term': 'Meningitis, Aseptic'}, {'id': 'D004675', 'term': 'Encephalitis, Tick-Borne'}, {'id': 'D020852', 'term': 'Lyme Neuroborreliosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D000212', 'term': 'Acyclovir'}], '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'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of full blood, serum and plasma will be collected and retained in deep freezer for further analyses.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-12-30', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis', 'timeFrame': 'at enrollment and during 12 months follow-up', 'description': 'Selected clinical parameters (presence or absence of headache, nausea, vomiting, neurologic symptoms, maximal temperature, etc) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.'}, {'measure': 'Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis', 'timeFrame': 'at enrollment and during 12 months follow-up', 'description': 'Selected laboratory parameters (complete blood count, biochemistry test results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.'}, {'measure': 'Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis', 'timeFrame': 'at enrollment and during 12 months follow-up', 'description': 'Selected microbiologic parameters (anti Borrelia burgdorferi immunoglobulin M and G in serum and cerebrospinal fluid results, polymerase chain reaction for enteroviruses, herpes simplex virus type 1 and 2 in cerebrospinal fluid results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and anti Borrelia burgdorferi immunoglobulin M and G in serum at follow-up visits: at 2, 6, and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aseptic meningitis', 'tick-borne encephalitis', 'Lyme neuroborreliosis', 'inflammation', 'outcome'], 'conditions': ['Aseptic Meningitis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is:\n\n* to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia\n* to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis\n* to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients with acute aseptic meningitis/meningoencephalitis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical picture compatible with aseptic meningitis/meningoencephalitis\n* age 18 years or older\n* clear cerebrospinal fluid on macroscopic examination\n* cerebrospinal pleocytosis (\\> 5 x 106 white blood cells per liter)\n\nExclusion Criteria:\n\n* younger than 18 years\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02328469', 'briefTitle': 'Aseptic Meningoencephalitis in Slovenia', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia', 'orgStudyIdInfo': {'id': 'mgt-0614'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unidentified aseptic meningitis', 'description': 'Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.', 'interventionNames': ['Drug: symptomatic therapy', 'Other: questionnaire']}, {'label': 'tick-borne encephalitis', 'description': 'Patient with aseptic meningitis in whom serological diagnosis of tick-borne encephalitis will be established. Patients will be treated with symptomatic therapy and will be asked to complete a questionnaire.', 'interventionNames': ['Drug: symptomatic therapy', 'Other: questionnaire']}, {'label': 'Lyme neuroborreliosis', 'description': 'Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire.', 'interventionNames': ['Drug: symptomatic therapy', 'Drug: Ceftriaxone or Doxycycline', 'Other: questionnaire']}, {'label': 'healthy controls', 'description': 'Patients will be asked to refer a spouse to serve as a control . If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control.', 'interventionNames': ['Drug: symptomatic therapy', 'Other: questionnaire']}, {'label': 'identified aseptic meningitis', 'description': 'Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire.', 'interventionNames': ['Drug: symptomatic therapy', 'Other: questionnaire', 'Drug: Acyclovir']}], 'interventions': [{'name': 'symptomatic therapy', 'type': 'DRUG', 'description': 'patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline', 'armGroupLabels': ['Lyme neuroborreliosis', 'healthy controls', 'identified aseptic meningitis', 'tick-borne encephalitis', 'unidentified aseptic meningitis']}, {'name': 'Ceftriaxone or Doxycycline', 'type': 'DRUG', 'description': 'beside symptomatic therapy (metamizole, paracetamol, thiethylperazine, saline), patients with proven or probable Lyme neuroborreliosis will be treated with ceftriaxone 2 g intravenously once daily for 14 days OR doxycycline 100 mg orally twice daily for 14 days', 'armGroupLabels': ['Lyme neuroborreliosis']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.', 'armGroupLabels': ['Lyme neuroborreliosis', 'healthy controls', 'identified aseptic meningitis', 'tick-borne encephalitis', 'unidentified aseptic meningitis']}, {'name': 'Acyclovir', 'type': 'DRUG', 'description': 'Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.', 'armGroupLabels': ['identified aseptic meningitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1525', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Daša Stupica, MD', 'role': 'CONTACT', 'email': 'dasa.stupica@kclj.si', 'phone': '+386 1 522 2110'}, {'name': 'Franc Strle, MD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 5222610'}, {'name': 'Daša Stupica, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Franc Strle, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1525', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Daša Stupica, MD, PhD', 'role': 'CONTACT', 'email': 'dasa.stupica@kclj.si', 'phone': '+386 1 522 2110'}, {'name': 'Franc Strle, MD, PhD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 522 2610'}], 'facility': 'UMC Ljubljana, Department of Infectious Diseases', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Daša Stupica, MD, PhD', 'role': 'CONTACT', 'email': 'dasa.stupica@kclj.si', 'phone': '+386 1 5222110'}, {'name': 'Franc Strle, MD, PhD', 'role': 'CONTACT', 'email': 'franc.strle@kclj.si', 'phone': '+386 1 5222610'}], 'overallOfficials': [{'name': 'Franc Strle, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Ljubljana'}, {'name': 'Daša Stupica, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Slovenian Research Agency', 'class': 'OTHER'}, {'name': 'University of Ljubljana School of Medicine, Slovenia', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Franc Strle', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}