An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
determine the efficacy of daptomycin to treat gram positive infections
Kevin High, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|