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Completed

NCT Number: NCT00396578

Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Infection Respiratory Tract Diseases Respiratory Tract Infections Tracheobronchitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Medical Center

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aerosolized vancomycin or gentamicin

Drug

Primary outcomes

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

Secondary outcomes

  1. Weaning from mechanical ventilation Bacterial resistance

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Nektar Therapeutics

Registry information

Official study title

Aerosolized Antibiotics in Mechanically Ventilated Patients

Important dates

Study start
2003
Study completion
2004
First posted
Nov 7, 2006
Registry last updated
Nov 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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