Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 1:54 PM
Study NCT ID:
NCT00470132
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2007-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventricular Shunt and Drain Infections - Timing of Reimplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2007-05-03', 'studyFirstSubmitQcDate': '2007-05-04', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ventricular shunt'], 'conditions': ['Ventricular Shunt Infection']}, 'descriptionModule': {'briefSummary': 'The retrospective study will help determine whether or not placement of new devices prior to the recommended time was associated with a high risk of relapse or treatment failure.', 'detailedDescription': "The following information will be collected from the medical record retrospectively: demographic data (age, gender, ethnicity, height, weight), past medical history, laboratory results, microbiologic data, data on the patients' devices (type of device, data that it was placed, exchanged or removed), treatment and clinical and microbiological outcomes. This will all be collected retrospectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'infected ventricular shunt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that were cared for by the PI for the purpose of treating an infected ventricular shunt or drainage device for the central nervous system.\n\nExclusion Criteria:\n\n* Those patients records that do not meet entry criteria'}, 'identificationModule': {'nctId': 'NCT00470132', 'briefTitle': 'Ventricular Shunt and Drain Infections - Timing of Reimplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Ventricular Shunt and Drain Infections - Timing of Reimplantation', 'orgStudyIdInfo': {'id': 'PRO07040262'}}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Karin Byers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of PIttsburgh and UPMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}