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Clinical Trials/NCT00396578
NCT00396578
Completed
Phase 2

Aerosolized Antibiotics in Mechanically Ventilated Patients

Stony Brook University1 site in 1 country80 target enrollmentAugust 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Ventilator Associated Pneumonia
Sponsor
Stony Brook University
Enrollment
80
Locations
1
Primary Endpoint
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2003
End Date
September 2004
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary Outcomes

  • Weaning from mechanical ventilation Bacterial resistance

Study Sites (1)

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