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Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396578
First Posted: November 7, 2006
Last Update Posted: November 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nektar Therapeutics
Information provided by:
Stony Brook University
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Aerosolized Antibiotics in Mechanically Ventilated Patients

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00396578     History of Changes
Other Study ID Numbers: CORIHS # 2004-3799
First Submitted: November 6, 2006
First Posted: November 7, 2006
Last Update Posted: November 7, 2006
Last Verified: November 2006

Keywords provided by Stony Brook University:
aerosolized antibiotics
ventilator associated pneumonia
clinical pulmonary infection score
bacterial resistance

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Respiratory Tract Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Bacterial Agents
Vancomycin
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action