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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01878643
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Respiratory Infection Bacterial Resistance Respiratory Failure Drug: vancomycin or gentamicin Drug: Placebo Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
Study Start Date : December 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878643


Locations
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United States, New York
University Hospital Medical Center
STony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Lucy B Palmer, MD Stony Brook University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01878643    
Other Study ID Numbers: 20033799
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013
Keywords provided by Stony Brook University:
aerosolized antibiotic
ventilator-associated pneumonia
bacterial resistance
ventilator -associated tracheobronchitis
clinical pulmonary infection score
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Insufficiency
Infection
Respiration Disorders
Respiratory Tract Diseases
Vancomycin
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action