Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

• Sponsor: Stony Brook University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00396578
• Collaborator: Nektar Therapeutics (Industry)
• Enrollment: 80
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 6.1

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
Ventilator Associated Pneumonia; Respiratory Infection; Tracheobronchitis	Drug: aerosolized vancomycin or gentamicin	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

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Aerosolized Antibiotics in Mechanically Ventilated Patients
• Study Start Date: Aug 1, 2003
• Study Completion Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

1. Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score []

Secondary Outcome Measures

1. Weaning from mechanical ventilation Bacterial resistance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• ClinicalTrials.gov Identifier: NCT00396578
• Other Study ID Numbers: CORIHS # 2004-3799
• First Posted: Nov 7, 2006
• Last Update Posted: Nov 7, 2006
• Last Verified: Nov 1, 2006

• Keywords provided by , ,: aerosolized antibiotics; ventilator associated pneumonia; clinical pulmonary infection score; bacterial resistance
• Additional relevant MeSH terms: Infections; Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Vancomycin; Gentamicins

Study Results

No Results Posted as of Nov 7, 2006