Bacterial InfectionsPhase 3NCT00288418
Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
A Phase 3 study testing Central Venous Catheter in people with Bacterial Infections, run by Angiotech Pharmaceuticals at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Central Venous Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35235
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, 22908
Pulmonary and Critical Care Medicine
Cincinnati, Ohio, 45267
Atlanta Institute for Medical Research Inc
Decatur, Georgia, 30030
Denver Health Medical Center
Denver, Colorado, 80204
Florida Research Network, LLC
Gainesville, Florida, 32605
Christiana Care Research Institute
Newark, Delaware, 19713
Newark Beth Israel Hospital
Newark, New Jersey, 07112
Universty of Oklahoma HSC
Oklahoma City, Oklahoma, 73104
Kerry Thibodeaux, M.D.
Opelousas, Louisiana, 70570
Pulmonary Consultant Group
Orange, California, 92868
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Rhode Island Hospital
Providence, Rhode Island, 02903
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Pulmonary Center Sharp Memorial Hospital
San Diego, California, 92123
Kaiser Permanente Santa Teresa
San Jose, California, 95119
Franciscan Health System Research Center
Tacoma, Washington, 98405
St Vincent Mercy Medical Center, Bldg 1
Toledo, Ohio, 43608
Medical University of Ohio
Toledo, Ohio, 43614
Winchester Medical Center
Winchester, Virginia, 22601
UMASS Medical School, Dept of Anesthesiology
Worcester, Massachusetts, 01655
About this study
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
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.
Read the 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:
- catheter-related local infection; and
- catheter-related bloodstream infection.
Safety Objectives: This study will assess the safety of the Angiotech CVC.
- Conditions
- Bacterial Infections
- Being tested
- Central Venous Catheter
- Keywords
- Colonization of the catheter, Catheter related bloodstream infection
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Venous CatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| ARROWgard Blue® CVC | Active comparator | 7-French x 20-cm, triple lumen, short-term CVC Receives: Device: Central Venous Catheter |
| Angiotech CVC | Experimental | 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 Receives: Device: Central Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen Heard, MD, Principal investigator, University of Mass. Medical School Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288418
- Sponsor's protocol ID
- 011-ACVC05
- Status last verified
- Jan 2013
- First submitted
- 6 Feb 2006
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00288418
- Acronym / sponsor ID
- 011-ACVC05
- Conditions
- Bacterial Infections
- Keywords
- Colonization of the catheter, Catheter related bloodstream infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Angiotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- catheter-related local infection; and
- catheter-related bloodstream infection.
Safety Objectives: This study will assess the safety of the Angiotech CVC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARROWgard Blue® CVC | Active comparator | Device: Central Venous Catheter7-French x 20-cm, triple lumen, short-term CVC |
| Angiotech CVC | Experimental | Device: Central Venous CatheterA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Venous Catheter7-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 | Device | ARROWgard Blue® CVC, Angiotech CVC |
Primary outcome
Incidence of catheter colonization
Time frame: Maximum of 28 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Heard, MD principal investigator
University of Mass. Medical School Department of Anesthesiology
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Central Venous Catheter in people with Bacterial Infections, run by Angiotech Pharmaceuticals at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter colonization (time frame: Maximum of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.