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

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

May 27, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid.

Change History

Complete list of historical versions of study NCT00148642 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

time to onset of mVAP
incidence of clinical VAP
duration of intubation
mortality
antibiotic usage
length of stay

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Multi-Center Clinical Trial of the Bard Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Respiratory Failure

Intervention ^ICMJE

Device: silver salts coated endotracheal tube
Device: uncoated endotracheal tube

Study Arms / Comparison Groups

Experimental: silver salts coated endotracheal tube
Placebo Comparator: uncoated endotracheal tube

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2003

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00148642

Responsible Party

Joan Dulin, CR Bard, Inc

Study ID Numbers ^ICMJE

5003A

Study Sponsor ^ICMJE

C. R. Bard

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marin H Kollef, MD

Barnes Jewish Hospital, St. Louis, MO

Information Provided By

C. R. Bard

Verification Date

May 2008

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