Back to resultsReduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
Primary Purpose
Respiratory Infection, Bacterial Resistance, Respiratory Failure
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
vancomycin or gentamicin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Infection focused on measuring aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score
Eligibility 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
Sites / Locations
- University Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Drug: Placebo
Drug: vancomycin or gentamicin
Arm Description
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
Outcomes
Primary Outcome Measures
Eradication of multi-drug resistant bacteria
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
Clinical Pulmonary Infection Score (CPIS)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01878643
Brief Title
Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
Official Title
Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection, Bacterial Resistance, Respiratory Failure
Keywords
aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
Arm Title
Drug: vancomycin or gentamicin
Arm Type
Experimental
Arm Description
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
Intervention Type
Drug
Intervention Name(s)
vancomycin or gentamicin
Other Intervention Name(s)
gentamicin sulfate, vancomycin hydrocloride
Intervention Description
Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline 2mL
Intervention Description
normal saline administered to patient via nebulization
Primary Outcome Measure Information:
Title
Eradication of multi-drug resistant bacteria
Description
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.
Time Frame
Randomization and at end of treatment
Secondary Outcome Measure Information:
Title
Clinical Pulmonary Infection Score (CPIS)
Description
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
Time Frame
Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy B Palmer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Medical Center
City
STony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24646034
Citation
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.
Results Reference
derived
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Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
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