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

September 6, 2005
May 27, 2008
November 2002
March 2006   (final data collection date for primary outcome measure)
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 ]
The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid.
Complete list of historical versions of study NCT00148642 on ClinicalTrials.gov Archive Site
  • 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 ]
  • time to onset of mVAP
  • incidence of clinical VAP
  • duration of intubation
  • mortality
  • antibiotic usage
  • length of stay
Not Provided
Not Provided
 
Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
Multi-Center Clinical Trial of the Bard Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Respiratory Failure
  • Device: silver salts coated endotracheal tube
    intubation with silver coated tube
    Other Name: Agento
  • Device: uncoated endotracheal tube
    intubation
  • Experimental: 1
    silver salts coated endotracheal tube
    Intervention: Device: silver salts coated endotracheal tube
  • Placebo Comparator: 2
    uncoated endotracheal tube
    Intervention: Device: uncoated endotracheal tube

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2003
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148642
5003A
Yes
Joan Dulin, CR Bard, Inc
C. R. Bard
Not Provided
Principal Investigator: Marin H Kollef, MD Barnes Jewish Hospital, St. Louis, MO
C. R. Bard
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP