Status:
WITHDRAWN
Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Infection
Neutropenia
Eligibility:
All Genders
Up to 120 years
Phase:
NA
Brief Summary
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 bact...
Detailed Description
OBJECTIVES: Primary * Compare the safety of daptomycin vs vancomycin in cancer patients with chemotherapy-induced neutropenia and gram-positive bacteremia. * Compare the efficacy of these drugs, in ...
Eligibility Criteria
Inclusion
- 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
- At least 0.2 colony-forming units/mL on lysis-centrifugation culture
- Currently receiving broad-spectrum antimicrobial therapy appropriate for febrile neutropenia
- No meningitis, endocarditis, osteomyelitis, or pneumonia (by clinical or radiologic criteria)
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 7 days
- No allergy or intolerance to vancomycin or daptomycin
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment
- No underlying myopathy or neurologic disease (e.g., Guillan-Barre or multiple sclerosis)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent HMG CoA reductase inhibitors (statins)
- No concurrent gemfibrozil or clofibrate
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00296049
Start Date
July 1 2005
End Date
March 1 2006
Last Update
August 10 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096