Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00280904
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2006-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmegeri1@its.jnj.com', 'phone': '1-508-828-8274', 'title': 'J. Thomas Megerian', 'organization': 'Codman & Shurtleff'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ventriculoperitoneal Shunt Patients', 'description': 'Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.', 'otherNumAtRisk': 433, 'otherNumAffected': 0, 'seriousNumAtRisk': 433, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventriculoperitoneal Shunt Patients', 'description': 'Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'April 2008', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Shunt Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventriculoperitoneal Shunt Patients', 'description': 'Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implantation to Explant', 'description': 'Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ventriculoperitoneal Shunt Patients', 'description': 'Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ventriculoperitoneal Shunt Patients', 'description': 'Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '183', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '193', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '25.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '239', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2006-01-20', 'resultsFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-05', 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Shunt Infections', 'timeFrame': 'Implantation to Explant', 'description': 'Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.'}], 'secondaryOutcomes': [{'measure': 'Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures', 'timeFrame': 'April 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydrocephalus', 'Shunt'], 'conditions': ['Hydrocephalus']}, 'referencesModule': {'references': [{'pmid': '20871445', 'type': 'RESULT', 'citation': 'Steinbok P, Milner R, Agrawal D, Farace E, Leung GK, Ng I, Tomita T, Wang E, Wang N, Wong GK, Zhou LF. A multicenter multinational registry for assessing ventriculoperitoneal shunt infections for hydrocephalus. Neurosurgery. 2010 Nov;67(5):1303-10. doi: 10.1227/NEU.0b013e3181f07e76.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.', 'detailedDescription': 'Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.\n\nDepending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%\n\nThis prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.\n\nThis Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry\n\nSubjects will be followed for up to 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of any age, gender and ethnicity, with hydrocephalus', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.\n* The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.\n* The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines \\& requirements.\n\nExclusion Criteria:\n\n* The Subject's planned shunt has distal drainage to the heart.\n* The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.\n* The Subject has ventriculitis, peritonitis or meningitis.\n* The Subject has sepsis.\n* The Subject has a history of poor wound healing.\n* The Subject has symptoms pertaining to: a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.\n* The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant\n* The Subject has loculation(s) within the ventricular system.\n* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.\n* The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.\n* The Subject exhibits other difficulties, which would preclude follow-up for 90 days.\n* The Subject is a prisoner."}, 'identificationModule': {'nctId': 'NCT00280904', 'briefTitle': 'A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codman & Shurtleff'}, 'officialTitle': 'A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus', 'orgStudyIdInfo': {'id': 'CRI-IN04-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Shunt catheter', 'type': 'DEVICE', 'description': 'standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ua Shan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'All India Insitute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Neuroscience Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Paul Steinbok, MBBS, FRCSC', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codman & Shurtleff', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}