Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-07 @ 1:03 AM
Study NCT ID:
NCT00197392
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmegeri1@its.jnj.com', 'phone': '508.880.8274', 'title': 'J. Thomas Megerian, MD', 'organization': 'Codman & Shurtleff, Inc'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard EVD', 'description': 'Subjects with standard EVD', 'otherNumAtRisk': 220, 'otherNumAffected': 11, 'seriousNumAtRisk': 220, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Bactiseal EVD', 'description': 'Subjects with Bactiseal EVD', 'otherNumAtRisk': 214, 'otherNumAffected': 19, 'seriousNumAtRisk': 214, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Blood positive for streptococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'CNS Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Coagulase negative staphylococcus in CSF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Confirmed dipthroid infection in CSF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF culture positive for coagulase negative staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF Positive for propionibacterium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF infection - entermococcus faecacil acinetobacter banmanii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF Infection - pseudomonas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Catheter tip - cultutre positive for coagulase negative staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Catheter occlusion due to hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Increrased intra-cranial pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sputum culture positive with gram positive cocci & gram negative diplococci', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sputum positive for gram negative & gram positive rods', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sputum positive for staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Stomach Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Trubid CSF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Urine positive for escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Vasovagal Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sputum Positive for Staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Sepsis secondary to pneumonia with complicating head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory culture positive for staphylocccus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory culture positive for enterobateraerogenes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Brain Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Respiratory culture positive for haemophilus influenzae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory culture positive for staphylocccus aureus-oxacillan resistant (orsa)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Throat culture positive for enterobacter aerogenes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Nares culture positive for oxacillan resistant staphylocccus aureus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF positive for coccidiodes immitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory culture positive for escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF culture positive for coagulase negative staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Epidural hematoma at ventriculostomy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'CSF infection with secondary hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Right intracerebral hemorhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Aseptic Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Blood Culture Positive for Coagulase Negative Staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Vasovagal Shock at EVD Explant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Patients treated with Codman Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Cathter', 'description': 'Patients treated with Standard EVD Catheter'}], 'classes': [{'title': 'Modified intent to Treat', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Per Protocol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of implanted EVD system to 2 week post implant', 'description': 'The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).', 'unitOfMeasure': 'Infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Proven Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Patients treated with Codman Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Patients treated with standard EVD catheter.'}], 'classes': [{'title': 'Modified Intent to Treat', 'categories': [{'measurements': [{'value': '9.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '10', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '9.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '10', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Per protocol', 'categories': [{'measurements': [{'value': '14', 'spread': '1', 'groupId': 'OG000'}, {'value': '10', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implantation of EVD System to explant of EVD catheter, an average of ten days', 'description': 'Number of days to proven infection.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Class of Bacterial Agent Causing Proven Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal - EVD Catheter', 'description': 'Patients treated with Bactiseal EVD catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Patient treated with Standard EVD Catheter'}], 'classes': [{'title': 'Bacilli', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gamma Proteobacteria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implantation of subject to post implant', 'description': 'Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects included in the MITT, Evaluable and Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Intraluminal Colonization on Catheters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Patients implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Patients implanted with Standard EVD Catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implant of subjects to post implant', 'description': 'Number of catheters with Bacterial colonization verified using fluorescence.', 'unitOfMeasure': 'catheters', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Patients implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Patients implanted with standard EVD catheter'}], 'classes': [{'title': 'Modifeid Intent to Treat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Per protocol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Safety', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implanted subjects to time of explant', 'description': 'Number of Device Related Adverse Events', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.'}, {'type': 'SECONDARY', 'title': 'Number of Days With Indwelling Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Patients implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Patients implanted with Standard EVD Catheter'}], 'classes': [{'title': 'Modified Intent to Treat', 'categories': [{'measurements': [{'value': '8.7', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '9.3', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Per Protocol', 'categories': [{'measurements': [{'value': '9.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant of subjects to day of explant', 'description': 'Days catheter was implanted in subjects', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Subject Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Subjects implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Subjects implanted with standard EVD catheter'}], 'classes': [{'title': 'Modified Intent to Treat', 'categories': [{'measurements': [{'value': '51.9', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '51.9', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Per protocol', 'categories': [{'measurements': [{'value': '49.4', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '14.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant to subject', 'description': 'The average subject age', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnosis Requiring EVD Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter and Standard EVD Cathter', 'description': 'Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.'}], 'classes': [{'title': 'Edema - Modified Intent to Treat', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Edema - Evaluable', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Edema - Per Protocol', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Hemorrhage - Modified Intent to Treat', 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}]}]}, {'title': 'Hemorrhage - Evaluable', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}]}]}, {'title': 'Hemorrhage - Per protocol', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}]}]}, {'title': 'Hydrocephalus - Modified Intent to Treat', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Hydrocephalus - Evaluable', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Hydrocephalus - Per Protocol', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implantation of EVD system', 'description': 'Primary diagnosis for implantation of EVD system', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis consisted of combining both Arm/Group (Bactiseal and Standard)'}, {'type': 'SECONDARY', 'title': 'Non-infectious Catheter Failure in the MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Subjects treated with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Subjects treated with standard EVD catheter'}], 'classes': [{'title': 'Occlusion', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Migration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Misplacement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implant of subject to explant', 'description': 'Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Point of Introduction of Systemic Antibiotic Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Subjects implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standrad EVD Catheter', 'description': 'Subjects implanted with standard EVD catheter'}], 'classes': [{'title': 'Before implant, but within 48 hours (MITT)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Catheter Implanted (MITT)', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': 'Before implant, but within 48 hours (Evaluable)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Catheter Implanted (Evaluable)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Before implant, but within 48 hours (Per protocol)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Catheter implanted (Per Protocol)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 48 hours of implant of subjects to explant', 'description': 'Time points of then patients received systemic antibiotic therapy', 'unitOfMeasure': 'Paticipants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Locations for EVD Catheter Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Subjects implanted with the Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Subjects implanted with a standard EVD catheter'}], 'classes': [{'title': 'ICU (MITT)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'OR (MITT)', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'ICU (Evaluable)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'OR (Evaluable)', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'ICU (Per Protocol)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'OR (Per Protocol)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implantation of subject', 'description': 'Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Catheter Tunneling Into the Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD Catheter', 'description': 'Subjects implanted with Bactiseal EVD Catheter'}, {'id': 'OG001', 'title': 'Standard EVD Catheter', 'description': 'Subjects implanted with a standard EVD catheter'}], 'classes': [{'title': 'MITT', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Evaluable', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Per Protocol', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant of subject', 'description': 'Length of tunneling of EVD catheter in the brain for each analysis population.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Catheter Insertion Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactiseal EVD', 'description': 'Subjects implanted with Bactiseal EVD catheters.'}, {'id': 'OG001', 'title': 'Standard EVD', 'description': 'Subjects implanted with Standard EVD catheters.'}], 'classes': [{'title': '1 Insertion', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}, {'title': '2 insertions', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3 instertions', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '4 instertions', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 insertions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implantation of subject', 'description': 'Number of insertions needed to place catheter', 'unitOfMeasure': 'insertions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bactiseal EVD', 'description': 'Subjects treated with Bactiseal EVD catheter'}, {'id': 'FG001', 'title': 'Conventional EVD Catheter', 'description': 'Subjects treated with Standard EVD catheter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'Modified Intent to Treat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'Evaluable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'Per Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '86'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bactiseal EVD'}, {'id': 'BG001', 'title': 'Standard EVD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '53.05', 'spread': '15.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 434}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-11', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infections', 'timeFrame': 'Duration of implanted EVD system to 2 week post implant', 'description': 'The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).'}], 'secondaryOutcomes': [{'measure': 'Days to Proven Infection', 'timeFrame': 'Implantation of EVD System to explant of EVD catheter, an average of ten days', 'description': 'Number of days to proven infection.'}, {'measure': 'Class of Bacterial Agent Causing Proven Infection', 'timeFrame': 'Implantation of subject to post implant', 'description': 'Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD'}, {'measure': 'Intraluminal Colonization on Catheters', 'timeFrame': 'Implant of subjects to post implant', 'description': 'Number of catheters with Bacterial colonization verified using fluorescence.'}, {'measure': 'Device Related Adverse Events', 'timeFrame': 'Implanted subjects to time of explant', 'description': 'Number of Device Related Adverse Events'}, {'measure': 'Number of Days With Indwelling Catheter', 'timeFrame': 'Implant of subjects to day of explant', 'description': 'Days catheter was implanted in subjects'}, {'measure': 'Average Subject Age', 'timeFrame': 'Implant to subject', 'description': 'The average subject age'}, {'measure': 'Diagnosis Requiring EVD Implantation', 'timeFrame': 'Implantation of EVD system', 'description': 'Primary diagnosis for implantation of EVD system'}, {'measure': 'Non-infectious Catheter Failure in the MITT Population', 'timeFrame': 'Implant of subject to explant', 'description': 'Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.'}, {'measure': 'Time Point of Introduction of Systemic Antibiotic Therapy', 'timeFrame': 'Within 48 hours of implant of subjects to explant', 'description': 'Time points of then patients received systemic antibiotic therapy'}, {'measure': 'Hospital Locations for EVD Catheter Placement', 'timeFrame': 'Implantation of subject', 'description': 'Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).'}, {'measure': 'Length of Catheter Tunneling Into the Brain', 'timeFrame': 'Implant of subject', 'description': 'Length of tunneling of EVD catheter in the brain for each analysis population.'}, {'measure': 'Number of Catheter Insertion Attempts', 'timeFrame': 'Implantation of subject', 'description': 'Number of insertions needed to place catheter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ventriculostomy', 'EVD'], 'conditions': ['Intraventricular Hemorrhage', 'Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Codman in house testing reports, TR2213 and PVER99-133 Addendum'}, {'type': 'BACKGROUND', 'citation': 'Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.'}, {'pmid': '2732730', 'type': 'BACKGROUND', 'citation': 'Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9. doi: 10.1136/jnnp.52.5.605.'}, {'pmid': '9254088', 'type': 'BACKGROUND', 'citation': 'Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51. doi: 10.3171/jns.1997.87.2.0247.'}, {'pmid': '14609161', 'type': 'BACKGROUND', 'citation': 'Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9. doi: 10.3171/jns.2003.99.5.0831.'}, {'pmid': '12182415', 'type': 'BACKGROUND', 'citation': 'Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.'}, {'pmid': '7841297', 'type': 'BACKGROUND', 'citation': 'Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000. doi: 10.1016/0142-9612(94)90080-9.'}, {'pmid': '12691395', 'type': 'BACKGROUND', 'citation': 'Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30. doi: 10.3171/jns.2003.98.4.0725.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study', 'detailedDescription': 'External ventricular drainage catheters are widely used in the management of Subjects with elevated intra-cranial pressure (ICP) secondary to acute hydrocephalus due to sub-arachnoid hemorrhage, intra-cerebral hemorrhage, intra-ventricular hemorrhage and other causes that obstruct the cerebrospinal fluid (CSF) circulation. However, this mode of treatment could be compromised by the increased risk of catheter related CSF infection.\n\nB-EVD is manufactured using a patented process to impregnate silicone catheters with two antibiotics, rifampin and clindamycin. These antibiotics are impregnated throughout the silicone matrix. After implantation, slow release of both antibiotics at the extra- and intra-luminal catheter surfaces minimizes the likelihood of bacterial colonization. The B-EVD Catheter System has, to date, been well accepted by domestic and European customers. Currently there exists sound scientific rationale and promising bench-top in vitro data to anticipate low levels of ventriculostomy-related infection in Subjects using this system. Published BACTISEAL shunt data and direct feedback from U.S. market experience also support this notion. There are no published clinical studies reporting infection rates with the use of the B-EVD System, making all statements regarding its propensity to minimize clinical risk for catheter-related infection mere speculation and anecdotal. Therefore, Codman proposes to undertake a controlled clinical evaluation of this product to demonstrate its influence on EVD catheter-related infections, using a conventional EVD catheter as a standard of reference.\n\nImmediately following successful screening, the Subject will be randomized to test or control group and will have the appropriate EVD system implanted. The Treatment Phase will cover the duration of the implanted EVD system. Subjects will be monitored for 2 weeks post-explant.\n\nThis study is expected to enroll 600 evaluable implanted Subjects at up to 15 Investigational Sites in US, Europe and Asia-Pacific'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The Subject is 18 years or older.\n* The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.\n* The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Within the preceding 30 days, the Subject has enrolled or participated in another trial utilizing an anti-microbial drug or medical device implanted in or directly influencing the CNS and/or spinal cord.\n* The Subject is pregnant or lactating.\n* The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.\n* The Subject has a positive CSF culture prior to EVD implant.\n* The Subject is immunocompromised.\n* The Subject requires more than one ventricular catheter concurrently.\n* The Subject has had an EVD catheter within the previous 30 days.\n* The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.\n* The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.\n* The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.\n* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.\n* The Subject is a prisoner.'}, 'identificationModule': {'nctId': 'NCT00197392', 'briefTitle': 'Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codman & Shurtleff'}, 'officialTitle': 'Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System', 'orgStudyIdInfo': {'id': 'BAC-IN02-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bactiseal TM EVD', 'description': 'Bactiseal External Ventricular Drainage System.', 'interventionNames': ['Device: Bactiseal TM EVD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard EVD Catheter', 'description': 'Standard External Ventricular Device system', 'interventionNames': ['Device: Standard EVD Catheter']}], 'interventions': [{'name': 'Bactiseal TM EVD', 'type': 'DEVICE', 'otherNames': ['EVD,Bactiseal, standard'], 'description': 'Standard of care implantation of external ventricular drainage catheter', 'armGroupLabels': ['Bactiseal TM EVD']}, {'name': 'Standard EVD Catheter', 'type': 'DEVICE', 'otherNames': ['EVD, ventricular catheters'], 'description': 'Standard of care EVD system other than Bactiseal.', 'armGroupLabels': ['Standard EVD Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '13213', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Xuan Wu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Angers', 'country': 'France', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': 'NO-0027', 'city': 'Oslo', 'country': 'Norway', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Neuroscience Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': 'BS 16 1LE', 'city': 'Bristol', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Leeds', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Salford', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}], 'overallOfficials': [{'name': 'J. Thomas Megerian, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unaffilliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codman & Shurtleff', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}