Clinical trial NCT00288418: Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
Official title: A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Keywords: Colonization of the catheter
Catheter related bloodstream infection
Lead sponsor: Angiotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

In 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.

Primary 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.

Secondary 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:

1. catheter-related local infection; and
2. catheter-related bloodstream infection.

Safety Objectives: This study will assess the safety of the Angiotech CVC.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* Be initially hospitalized in an intensive care setting
* Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
* If female and of child-bearing potential, provide evidence of a negative pregnancy test

Exclusion Criteria:

* Has a life expectancy of less than one month
* Is pregnant
* Has a history of anaphylactic reactions, including reactions to contrast dyes
* Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine

Primary outcomes:
measure: Incidence of catheter colonization
timeFrame: Maximum of 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, P.C.
state: Alabama
city: Orange
country: United States
facility: Pulmonary Consultant Group
state: California
city: San Diego
country: United States
facility: Pulmonary Center Sharp Memorial Hospital
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Santa Teresa
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Research Institute
state: Delaware
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research Inc
state: Georgia
city: Opelousas
country: United States
facility: Kerry Thibodeaux, M.D.
state: Louisiana
city: Worcester
country: United States
facility: UMASS Medical School, Dept of Anesthesiology
state: Massachusetts
city: Newark
country: United States
facility: Newark Beth Israel Hospital
state: New Jersey
city: Cincinnati
country: United States
facility: Pulmonary and Critical Care Medicine
state: Ohio
city: Toledo
country: United States
facility: St Vincent Mercy Medical Center, Bldg 1
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Universty of Oklahoma HSC
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Charlottesville
country: United States
facility: University of Virginia, Department of Anesthesiology
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Franciscan Health System Research Center
state: Washington
Study officials:
affiliation: University of Mass. Medical School Department of Anesthesiology
name: Stephen Heard, MD
role: PRINCIPAL_INVESTIGATOR
References: