Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288418
• Other study ID #: 011-ACVC05
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2006
• Last updated: January 22, 2013
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: January 2013
• Source: Angiotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Device:
• Central Venous Catheter
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

Locations

Country	Name	City	State
United States	Cardio-Thoracic Surgeons, P.C.	Birmingham	Alabama
United States	University of Virginia, Department of Anesthesiology	Charlottesville	Virginia
United States	Pulmonary and Critical Care Medicine	Cincinnati	Ohio
United States	Atlanta Institute for Medical Research Inc	Decatur	Georgia
United States	Denver Health Medical Center	Denver	Colorado
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Christiana Care Research Institute	Newark	Delaware
United States	Newark Beth Israel Hospital	Newark	New Jersey
United States	Universty of Oklahoma HSC	Oklahoma City	Oklahoma
United States	Kerry Thibodeaux, M.D.	Opelousas	Louisiana
United States	Pulmonary Consultant Group	Orange	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Pulmonary Center Sharp Memorial Hospital	San Diego	California
United States	Kaiser Permanente Santa Teresa	San Jose	California
United States	Franciscan Health System Research Center	Tacoma	Washington
United States	Medical University of Ohio	Toledo	Ohio
United States	St Vincent Mercy Medical Center, Bldg 1	Toledo	Ohio
United States	Winchester Medical Center	Winchester	Virginia
United States	UMASS Medical School, Dept of Anesthesiology	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Angiotech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter colonization	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.	Maximum of 28 days	No