Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients
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
- 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.
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