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Completed

NCT Number: NCT01878643

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

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

Completed

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Key information

Conditions

Respiratory Infection Bacterial Resistance Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital Medical Center

Stony Brook, New York, 11794, United States

About this study

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

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

Exclusion criteria

  • pregnancy
  • allergy to drugs administered

Treatment and study plan

vancomycin or gentamicin

Drug

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

Placebo

Drug

normal saline administered to patient via nebulization

Other names: Normal saline 2mL

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jun 17, 2013
Registry last updated
Jun 17, 2013

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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