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The purpose of this study was :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Placebo | Placebo Comparator | normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin |
|
| Drug: vancomycin or gentamicin | Experimental | vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vancomycin or gentamicin | Drug | Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy B Palmer, MD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Medical Center | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24646034 | Derived | 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. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D012131 | Respiratory Insufficiency |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000077299 | Healthcare-Associated Pneumonia |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D005839 | Gentamicins |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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|
| Placebo | Drug | normal saline administered to patient via nebulization |
|
|
| D003428 | Cross Infection |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |