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CompletedNCT00396578Updated Nov 7, 2006

Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

A Phase 2 interventional study of aerosolized vancomycin or gentamicin in Ventilator Associated Pneumonia, Respiratory Infection and Tracheobronchitis, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-07.

Sponsored by Stony Brook University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

Read the detailed description

In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

02

Conditions studied

  • Ventilator Associated Pneumonia
  • Respiratory Infection
  • Tracheobronchitis

Keywords

  • aerosolized antibiotics
  • ventilator associated pneumonia
  • clinical pulmonary infection score
  • bacterial resistance
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 80 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • be on mechanical ventilation greater than 3 days
  • greater than or equal to 18 years of age survival greater than 14 days
  • greater than 2 ccs of tracheal secretions/4 hours

Exclusion criteria

Exclusion Criteria:

  • allergy to drugs, pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants

Interventions

  • Drugaerosolized vancomycin or gentamicin
06

What researchers measure

Primary outcomes

  1. Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary outcomes

  1. Weaning from mechanical ventilation Bacterial resistance

07

Study locations

1 site
  • University Hospital Medical Center
    Stony Brook, New York 11794, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00396578
Lead sponsor
Stony Brook University
Collaborators
Nektar Therapeutics
First posted
Nov 7, 2006
Start date
Aug 2003
Completion
Sep 2004
Last update
Nov 7, 2006

Study contacts

Lucy B Palmer, MD
principal investigator · SUNY at Stony Brook
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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