Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00925093
Status:
WITHDRAWN
Last Update Posted:
2015-01-26
First Post:
2009-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D017334', 'term': 'Teicoplanin'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077427', 'term': 'Lipoglycopeptides'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Primary investigator left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of antibiotics in cerebrospinal fluid', 'timeFrame': '1, 2, 4, 6, 12 hours', 'description': 'Concentration in CSF past i.v. injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vancomycin', 'teicoplanin', 'linezolid', 'intravenous', 'cerebrospinal fluid', 'CSF', 'pharmacokinetics', 'penetration', 'blood-brain barrier', 'Pharmacokinetics of three antibiotics in relation to cerebrospinal fluid'], 'conditions': ['Neurosurgery']}, 'descriptionModule': {'briefSummary': 'Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Already having an external CSF drain\n* Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")\n\nExclusion Criteria:\n\n* Infection or colonization requiring other than standard prophylactic antibiotics'}, 'identificationModule': {'nctId': 'NCT00925093', 'briefTitle': 'Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Antibiotics in Cerebrospinal Fluid Following Intravenous Injection', 'orgStudyIdInfo': {'id': 'AUH-MGP-AB-CSV-2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teicoplanin', 'description': 'Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'interventionNames': ['Drug: Teicoplanin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Linezolid', 'description': 'Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'armGroupLabels': ['Vancomycin']}, {'name': 'Teicoplanin', 'type': 'DRUG', 'description': 'Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'armGroupLabels': ['Teicoplanin']}, {'name': 'Linezolid', 'type': 'DRUG', 'description': 'Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample', 'armGroupLabels': ['Linezolid']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Morten Gustav Poulsen, MD', 'oldOrganization': 'Aarhus University Hospital, Aarhus Hospital'}}}}