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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance

Conditions
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Respiratory Infection, Bacterial Resistance, Respiratory Failure

Intervention / Treatment
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* Drug: vancomycin or gentamicin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Drug: Placebo<br>normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin | Drug: Placebo<br>* normal saline administered to patient via nebulization<br>* Other names: Normal saline 2mL;|
| Experimental: Drug: vancomycin or gentamicin<br>vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours | Drug: vancomycin or gentamicin<br>* Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours<br>* Other names: vancomycin hydrocloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Randomization and at end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerosolized antibiotic, ventilator-associated pneumonia, bacterial resistance, ventilator -associated tracheobronchitis, clinical pulmonary infection score