Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP) (NASCENT)

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00148642
First received: September 6, 2005
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to determine if the use of a silver-coated endotracheal tube (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.


Condition Intervention Phase
Respiratory Failure
Device: silver salts coated endotracheal tube
Device: uncoated endotracheal tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Clinical Trial of the Bard Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to onset of mVAP in subjects intubated for >=24 hours [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • incidence of clinical VAP in subjects intubed for >=24 hours [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • duration of intubation [ Time Frame: unlimited ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: unlimited ] [ Designated as safety issue: Yes ]
  • antibiotic usage [ Time Frame: unlimited ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: unlimited ] [ Designated as safety issue: Yes ]

Enrollment: 2003
Study Start Date: November 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
silver salts coated endotracheal tube
Device: silver salts coated endotracheal tube
intubation with silver coated tube
Other Name: Agento
Placebo Comparator: 2
uncoated endotracheal tube
Device: uncoated endotracheal tube
intubation

Detailed Description:

Nosocomial pneumonia is the leading cause of death from hospital-acquired infections.Ventilator associated pneumonia (VAP) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. Silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. Bard has developed a proprietary antimicrobial ETT, manufactured with a hydrophilic coating containing a fine dispersion of silver salts.

This study compare the incidence and time to onset of VAP in patients intubated for >=24 hours with a proprietary silver-coated ETT versus those intubated for >= 24 hours with a standard non-coated ETT.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • expected to be intubated for at least 24 hours
  • able to sign Informed Consent

Exclusion Criteria:

  • symptoms of bronchiectasis
  • severe hemoptysis
  • history of cystic fibrosis
  • intubated > 12 hours within previous 30 days
  • pregnancy
  • participating in a competing trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148642

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Illinois
West Suburban Hospital
Oak Park, Illinois, United States, 60302
United States, Minnesota
Mayo Clinic & Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Texas
Audie Murphy VA Medical Center & University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Marin H Kollef, MD Barnes Jewish Hospital, St. Louis, MO
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joan Dulin, CR Bard, Inc
ClinicalTrials.gov Identifier: NCT00148642     History of Changes
Other Study ID Numbers: 5003A
Study First Received: September 6, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
ventilator-associated pneumonia
nosocomial pneumonia

Additional relevant MeSH terms:
Pneumonia
Respiratory Insufficiency
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 24, 2014