Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00288418
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2006-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062905', 'term': 'Central Venous Catheters'}], 'ancestors': [{'id': 'D062666', 'term': 'Vascular Access Devices'}, {'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 960}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of catheter colonization', 'timeFrame': 'Maximum of 28 days', 'description': 'Primary Objective: The primary objective of this study was to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonization of the catheter', 'Catheter related bloodstream infection'], 'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine if the Angiotech central venous catheter (CVC) is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization. Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream infection. This study will also assess the safety of the Angiotech CVC.', 'detailedDescription': 'Central venous catheters are widely used for hemodynamic monitoring and the administration of fluids, drugs, and nutrition. The most frequent life-threatening complication of central venous catheter use is septicemia. Normal cutaneous flora may invade the intracutaneous tract during or after catheter insertion. The colonizing bacteria subsequently disseminate along the catheter surface and ultimately seed into the blood stream.\n\nIn the United States, a total of 250,000 cases of central venous catheter-related infections are estimated annually. Costs per infection are estimated as high as US$56,000. It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance.\n\nPrimary Objective: The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.\n\nSecondary Objectives: The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue® CVC to prevent:\n\n1. catheter-related local infection; and\n2. catheter-related bloodstream infection.\n\nSafety Objectives: This study will assess the safety of the Angiotech CVC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n* Be initially hospitalized in an intensive care setting\n* Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days\n* If female and of child-bearing potential, provide evidence of a negative pregnancy test\n\nExclusion Criteria:\n\n* Has a life expectancy of less than one month\n* Is pregnant\n* Has a history of anaphylactic reactions, including reactions to contrast dyes\n* Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine'}, 'identificationModule': {'nctId': 'NCT00288418', 'briefTitle': 'Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiotech Pharmaceuticals'}, 'officialTitle': 'A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters', 'orgStudyIdInfo': {'id': '011-ACVC05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARROWgard Blue® CVC', 'description': '7-French x 20-cm, triple lumen, short-term CVC', 'interventionNames': ['Device: Central Venous Catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Angiotech CVC', 'description': 'A 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU', 'interventionNames': ['Device: Central Venous Catheter']}], 'interventions': [{'name': 'Central Venous Catheter', 'type': 'DEVICE', 'description': '7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU', 'armGroupLabels': ['ARROWgard Blue® CVC', 'Angiotech CVC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardio-Thoracic Surgeons, P.C.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Pulmonary Consultant Group', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pulmonary Center Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Santa Teresa', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Research Institute', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Research Network, LLC', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute for Medical Research Inc', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '70570', 'city': 'Opelousas', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Kerry Thibodeaux, M.D.', 'geoPoint': {'lat': 30.53353, 'lon': -92.08151}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Medical School, Dept of Anesthesiology', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pulmonary and Critical Care Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'St Vincent Mercy Medical Center, Bldg 1', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medical University of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Universty of Oklahoma HSC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University College of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Rapid City Regional Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia, Department of Anesthesiology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Winchester Medical Center', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Franciscan Health System Research Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Stephen Heard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mass. Medical School Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiotech Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rui Avelar/ CMO', 'oldOrganization': 'Angiotech'}}}}