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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-98804 | |||
| CUBIST-CCCWFU-98804 | |||
| CCCWFU-BG04-494 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating bacteria in the blood. It is not yet known whether daptomycin is more effective than vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works compared with vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.
OBJECTIVES:
Primary
OUTLINE: This is an open-label, randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed at 6 and 12 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vancomycin | Active Comparator |
| |
| daptomycin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daptomycin | Drug |
| ||
| vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| determine the efficacy of daptomycin to treat gram positive infections | day 7 | |
| determine the safety of daptomycin in neutropenic patients | day 7 |
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DISEASE CHARACTERISTICS:
Diagnosis of a malignancy
Chemotherapy-induced neutropenia (absolute neutrophil count < 500/mm^3)
Two or more blood cultures positive for gram-positive cocci
Currently receiving broad-spectrum antimicrobial therapy appropriate for febrile neutropenia
No meningitis, endocarditis, osteomyelitis, or pneumonia (by clinical or radiologic criteria)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin High, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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|
| ID | Term |
|---|---|
| D007239 | Infections |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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