Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
NCT ID: NCT01878643
Last Updated: 2013-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
47 participants
INTERVENTIONAL
2001-12-31
2002-12-31
Brief Summary
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* to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
* to determine the effect of inhaled antibiotics on respiratory infection
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Detailed Description
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Systemic antibiotics are administered by the responsible physician
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug: Placebo
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
Placebo
normal saline administered to patient via nebulization
Drug: vancomycin or gentamicin
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
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
Interventions
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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
Placebo
normal saline administered to patient via nebulization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* greater than or equal to 18 years and survival greater than 14 days
* organisms on Gram stain with increasing purulent secretions
Exclusion Criteria
* allergy to drugs administered
18 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Principal Investigators
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Lucy B Palmer, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Locations
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University Hospital Medical Center
Stony Brook, New York, United States
Countries
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References
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Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.
Other Identifiers
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20033799
Identifier Type: -
Identifier Source: org_study_id
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