Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, infection, neutropenia, unspecified childhood solid tumor, protocol specific
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 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.
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 terms of fever resolution, bacteremia resolution, inflammation indicators reduction, implanted catheter salvage, and reduced need for antifungal therapy, in these patients. OUTLINE: This is an open-label, randomized, pilot study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive daptomycin IV over 30 minutes once daily. * Arm II: Patients receive vancomycin IV over 60 minutes twice daily. Treatment in both arms continues for approximately 7-14 days or until microbiologic failure, unsatisfactory clinical (symptomatic) response, or fever and neutropenia is resolved (absolute neutrophil count ≥ 1,000/mm\^3 on ≥ 2 consecutive days). Patients may be removed from the study if the isolate is found to be sensitive to the original antibiotics or resistant to either of the study drugs. 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.
Interventions
DRUGdaptomycin
DRUGvancomycin
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determine the efficacy of daptomycin to treat gram positive infections | day 7 |
| determine the safety of daptomycin in neutropenic patients | day 7 |
Countries
United States
Outcome results
None listed