Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
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ClinicalTrials.gov Identifier: NCT01878643 |
Recruitment Status :
Completed
First Posted : June 17, 2013
Last Update Posted : June 17, 2013
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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 |
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Respiratory Infection Bacterial Resistance Respiratory Failure | Drug: vancomycin or gentamicin Drug: Placebo | Early Phase 1 |
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 |
Arm | Intervention/treatment |
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Placebo Comparator: Drug: Placebo
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
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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
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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:
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- 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.
- 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 |
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

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
United States, New York | |
University Hospital Medical Center | |
STony Brook, New York, United States, 11794 |
Principal Investigator: | Lucy B Palmer, MD | Stony Brook University |
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 |
aerosolized antibiotic ventilator-associated pneumonia bacterial resistance ventilator -associated tracheobronchitis clinical pulmonary infection score |
Respiratory Tract Infections Respiratory Insufficiency Infections Respiration Disorders Respiratory Tract Diseases Vancomycin |
Gentamicins Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |