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| ID | Type | Description | Link |
|---|---|---|---|
| A5951069 |
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Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 1 gram IV every 12 hours for 7 to 14 days |
| |
| Linezolid |
| Measure | Description | Time Frame |
|---|---|---|
| To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin. | 72-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To compare duration of mechanical ventilation | 0000 | |
| To compare post treatment tracheal colonization | FU: 14 days after EOT +/- 2 days | |
| To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85006 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18719064 | Derived | Wunderink RG, Mendelson MH, Somero MS, Fabian TC, May AK, Bhattacharyya H, Leeper KV Jr, Solomkin JS. Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. Chest. 2008 Dec;134(6):1200-1207. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21. |
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| Drug |
600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days |
|
| EOT: Day 14; FU: 14 days after EOT +/- 2 days |
| To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure | 72-96 hours |
| To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU | EOT: Day 14; FU: 14 days after EOT +/- 2 days |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Pfizer Investigational Site | Palm Springs | California | 92262 | United States |
| Pfizer Investigational Site | Rancho Mirage | California | 92270 | United States |
| Pfizer Investigational Site | Redlands | California | 92373 | United States |
| Pfizer Investigational Site | Sacramento | California | 95819 | United States |
| Pfizer Investigational Site | Sacramento | California | 95829 | United States |
| Pfizer Investigational Site | Norwalk | Connecticut | 06850 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06721 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30909 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | North East Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | North East Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | North East Atlanta | Georgia | 30329 | United States |
| Pfizer Investigational Site | ‘Ewa Beach | Hawaii | 96706 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61603 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61636 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61637 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40536 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40206 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14215 | United States |
| Pfizer Investigational Site | Cortland Manor | New York | 10567 | United States |
| Pfizer Investigational Site | Jamaica | New York | 11418 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10467 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0559 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38103 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38104 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38163 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37212-3375 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99204 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99216 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99220 | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | 26505 | United States |
| Pfizer Investigational Site | San Juan | 00921-3201 | Puerto Rico |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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