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Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Information source: Stony Brook University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ventilator Associated Pneumonia; Respiratory Infection; Tracheobronchitis

Intervention: aerosolized vancomycin or gentamicin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Stony Brook University

Official(s) and/or principal investigator(s):
Lucy B Palmer, MD, Principal Investigator, Affiliation: SUNY at Stony Brook

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.

Clinical Details

Official title: Aerosolized Antibiotics in Mechanically Ventilated Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary outcome: Weaning from mechanical ventilation Bacterial 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University Hospital Medical Center, Stony Brook, New York 11794, United States
Additional Information

Starting date: August 2003
Last updated: November 6, 2006

Page last updated: August 23, 2015

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