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| ID | Type | Description | Link |
|---|---|---|---|
| A5951059 |
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This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. | Experimental | Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days. |
|
| B. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linezolid | Drug | 600mg every 12 hours |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections. | 7-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiologic outcome | 7-28 days | |
| Pathogen eradication (eradication rates of individual pathogens) | 7-28 days | |
| Defervescence (defined as Tmax orally or rectally) |
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Inclusion Criteria:
Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).
Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.
Exclusion Criteria:
Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.
Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
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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 | Los Angeles | California | 90033 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| vancomycin |
| Drug |
1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours. |
|
| 7-28 days |
| Time to defervescence | 7-28 days |
| Resolution of neutropenia (return of ANC to >500 cells/mm3) | 7-28 days |
| Time to resolution of neutropenia | 7-28 days |
| Mortality rate (survival at 7 days after the end of therapy) | 7-28 days |
| Springfield |
| Illinois |
| 62701-1014 |
| United States |
| Pfizer Investigational Site | Springfield | Illinois | 62703 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62769 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62781 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10461 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10467 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23226 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23229 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23249 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294-4367 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Federal Way | Washington | 98003 | United States |
| Pfizer Investigational Site | Lakewood | Washington | 98499 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98405 | United States |
| Pfizer Investigational Site | Buenos Aires | 1094 | Argentina |
| Pfizer Investigational Site | Córdoba | 5000 | Argentina |
| Pfizer Investigational Site | Mendoza | 5500 | Argentina |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01409-902 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01509-900 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04024-002 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 05651-901 | Brazil |
| Pfizer Investigational Site | Santiago | Chile |
| Pfizer Investigational Site | Bogotá | Bogota. DC | NAP | Colombia |
| Pfizer Investigational Site | Bogotá | Bogota. DC | Colombia |
| Pfizer Investigational Site | Medellín | Colombia |
| Pfizer Investigational Site | Helsinki | FIN-00029 HYKS | Finland |
| Pfizer Investigational Site | Zapopan | Jalisco | 45173 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | C.P. 64000 | Mexico |
| Pfizer Investigational Site | Mexico City | C.P. 02990 | Mexico |
| Pfizer Investigational Site | Lahore | Punjab Province | Pakistan |
| Pfizer Investigational Site | Karachi | 74800 | Pakistan |
| Pfizer Investigational Site | Lima | Lima Province | 13 | Peru |
| Pfizer Investigational Site | Lima | Lima Province | 34 | Peru |
| Pfizer Investigational Site | Caracas | Distrito Federal | 1041 | Venezuela |
| Pfizer Investigational Site | Caracas | 1020 | Venezuela |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| 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 |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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