Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

November 6, 2006 updated by: Stony Brook University

Aerosolized Antibiotics in Mechanically Ventilated Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • University Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score

Secondary Outcome Measures

Outcome Measure
Weaning from mechanical ventilation Bacterial resistance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

Nektar Therapeutics

Investigators

  • Principal Investigator: Lucy B Palmer, MD, SUNY At Stony Brook

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria

November 6, 2006

First Posted (ESTIMATE)

November 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2006

Last Update Submitted That Met QC Criteria

November 6, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORIHS # 2004-3799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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