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

This study has been completed.
Sponsor:
Information provided by:
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00288418
First received: February 6, 2006
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
 Device: Central Venous Catheter
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of catheter colonization [ Time Frame: Maximum of 28 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 960
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARROWgard Blue® CVC
7-French x 20-cm, triple lumen, short-term CVC
 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
Experimental: Angiotech CVC
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
 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288418

  Show 21 Study Locations
Sponsors and Collaborators
Angiotech Pharmaceuticals
Investigators
Principal Investigator: Stephen Heard, MD University of Mass. Medical School Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Rui Avelar/ CMO, Angiotech
ClinicalTrials.gov Identifier: NCT00288418     History of Changes
Other Study ID Numbers: 011-ACVC05
Study First Received: February 6, 2006
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:
Colonization of the catheter
Catheter related bloodstream infection

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013