Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
Primary Purpose
Ventilator Associated Pneumonia, Respiratory Infection, Tracheobronchitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aerosolized vancomycin or gentamicin
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance
Eligibility Criteria
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:
- allergy to drugs, pregnancy
Sites / Locations
- University Hospital Medical Center
Outcomes
Primary Outcome Measures
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Secondary Outcome Measures
Weaning from mechanical ventilation Bacterial resistance
Full Information
NCT ID
NCT00396578
First Posted
November 6, 2006
Last Updated
November 6, 2006
Sponsor
Stony Brook University
Collaborators
Nektar Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00396578
Brief Title
Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
Official Title
Aerosolized Antibiotics in Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stony Brook University
Collaborators
Nektar Therapeutics
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Respiratory Infection, Tracheobronchitis
Keywords
aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aerosolized vancomycin or gentamicin
Primary Outcome Measure Information:
Title
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Secondary Outcome Measure Information:
Title
Weaning from mechanical ventilation Bacterial resistance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
allergy to drugs, pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy B Palmer, MD
Organizational Affiliation
SUNY at Stony Brook
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
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