Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation - Full Text View

Purpose

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	Intervention	Phase
Ventilator Associated Pneumonia Respiratory Infection Tracheobronchitis	Drug: aerosolized vancomycin or gentamicin	Phase II

MedlinePlus related topics:

Antibiotics Pneumonia

Drug Information available for:

Vancomycin Gentamicins Vancomycin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Aerosolized Antibiotics in Mechanically Ventilated Patients

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary Outcome Measures:

Weaning from mechanical ventilation Bacterial resistance

Estimated Enrollment:	80
Study Start Date:	August 2003
Estimated Study Completion Date:	September 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396578

Locations


United States, New York
	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

More Information

Study ID Numbers:	CORIHS # 2004-3799
First Received:	November 6, 2006
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00396578
Health Authority:	United States: Institutional Review Board

Keywords provided by Stony Brook University:

aerosolized antibiotics

ventilator associated pneumonia

clinical pulmonary infection score

bacterial resistance

Study placed in the following topic categories:

Respiratory Tract Diseases

Respiratory Tract Infections

Lung Diseases

Gentamicins

Vancomycin

Pneumonia, Ventilator-Associated

Cross Infection

Pneumonia

Additional relevant MeSH terms:

Protein Synthesis Inhibitors

Anti-Infective Agents

Anti-Bacterial Agents

Communicable Diseases

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	Stony Brook University Nektar Therapeutics
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00396578