Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit

June 12, 2013 updated by: Stony Brook University

Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance

The purpose of this study was :

  • to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
  • to determine the effect of inhaled antibiotics on respiratory infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.

Systemic antibiotics are administered by the responsible physician

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Early Phase 1

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 and survival greater than 14 days
  • organisms on Gram stain with increasing purulent secretions

Exclusion Criteria:

  • pregnancy
  • allergy to drugs administered

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Drug: Placebo
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
Drug: Placebo
normal saline administered to patient via nebulization
Other Names:
  • Normal saline 2mL
Experimental: Drug: vancomycin or gentamicin
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
Drug: vancomycin or gentamicin
Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours
Other Names:
  • gentamicin sulfate
  • vancomycin hydrocloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication of multi-drug resistant bacteria
Time Frame: Randomization and at end of treatment

Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first).

Eradication is defined as absence of growth in culture and absence of organisms on Gram stain.
Randomization and at end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pulmonary Infection Score (CPIS)
Time Frame: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.
CPIS is an index for risk of respiratory infection using a number of signs and symptoms . An index of greater than or equal to 6 suggests pneumonia
Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.

Collaborators and Investigators

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

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Lucy B Palmer, MD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20033799

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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