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Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

This study has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00396578
First received: November 6, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Aerosolized Antibiotics in Mechanically Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Bronchitis
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Infection
Bronchial Diseases
Lung Diseases, Obstructive
Cross Infection
Ventilator-Induced Lung Injury
 Lung Injury
Anti-Bacterial Agents
Gentamicins
Vancomycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013