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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
Stony Brook University
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 6, 2006
Last Updated
November 6, 2006
Sponsor
Stony Brook University
Collaborators
Nektar Therapeutics
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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

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Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

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