Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score []
Secondary Outcome Measures
- Weaning from mechanical ventilation Bacterial resistance []
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital Medical Center | Stony Brook | New York | United States | 11794 |
Sponsors and Collaborators
- Stony Brook University
- Nektar Therapeutics
Investigators
- Principal Investigator: Lucy B Palmer, MD, SUNY at Stony Brook
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CORIHS # 2004-3799