Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Phase 2

Completed

• Conditions: Ventilator Associated Pneumonia; Respiratory Infection; Tracheobronchitis

• Registration Number: NCT00396578
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study Start: 2003-08
• Study Completion: 2004-09
• Status Verified: 2006-11
• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Last Update Submitted: 2006-11-06
• Study First Posted: 2006-11-07
• Last Update Posted: 2006-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary Outcome Measures

Name	Time	Method
Weaning from mechanical ventilation Bacterial resistance

Trial Locations

Locations (1)

University Hospital Medical Center; 🇺🇸 Stony Brook, New York, United States