NCT00148642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,003

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2002

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

September 6, 2005

Last Update Submit

January 14, 2017

Conditions

Respiratory Failure

Keywords

ventilator-associated pneumonianosocomial pneumonia

Outcome Measures

Primary Outcomes (1)

  • The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.

    30 days

Secondary Outcomes (6)

  • time to onset of mVAP in subjects intubated for >=24 hours

    30 days

  • incidence of clinical VAP in subjects intubed for >=24 hours

    30 days

  • duration of intubation

    unlimited

  • mortality

    unlimited

  • antibiotic usage

    unlimited

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

silver salts coated endotracheal tube

Device: silver salts coated endotracheal tube

2

PLACEBO COMPARATOR

uncoated endotracheal tube

Device: uncoated endotracheal tube

Interventions

silver salts coated endotracheal tubeDEVICE

intubation with silver coated tube

Also known as: Agento
1
uncoated endotracheal tubeDEVICE

intubation

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • symptoms of bronchiectasis
  • severe hemoptysis
  • history of cystic fibrosis
  • intubated \> 12 hours within previous 30 days
  • pregnancy
  • participating in a competing trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, San Diego

San Diego, California, 92103, United States

Location

West Suburban Hospital

Oak Park, Illinois, 60302, United States

Location

Mayo Clinic & Foundation

Rochester, Minnesota, 55905, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Audie Murphy VA Medical Center & University Hospital

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

  • Baughman RP, Spencer RE, Kleykamp BO, Rashkin MC, Douthit MM. Ventilator associated pneumonia: quality of nonbronchoscopic bronchoalveolar lavage sample affects diagnostic yield. Eur Respir J. 2000 Dec;16(6):1152-7. doi: 10.1034/j.1399-3003.2000.16f23.x.

    PMID: 11292122BACKGROUND

  • Restrepo MI, Anzueto A, Arroliga AC, Afessa B, Atkinson MJ, Ho NJ, Schinner R, Bracken RL, Kollef MH. Economic burden of ventilator-associated pneumonia based on total resource utilization. Infect Control Hosp Epidemiol. 2010 May;31(5):509-15. doi: 10.1086/651669.

    PMID: 20302428DERIVED

  • Kollef MH, Afessa B, Anzueto A, Veremakis C, Kerr KM, Margolis BD, Craven DE, Roberts PR, Arroliga AC, Hubmayr RD, Restrepo MI, Auger WR, Schinner R; NASCENT Investigation Group. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA. 2008 Aug 20;300(7):805-13. doi: 10.1001/jama.300.7.805.

    PMID: 18714060DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyPneumonia, Ventilator-AssociatedHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marin H Kollef, MD

    Barnes Jewish Hospital, St. Louis, MO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

November 1, 2002

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

US(5)