RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
OBJECTIVES: I. Compare the efficacy of piperacillin and tazobactam with or without vancomycin in reducing fever in patients with hematological malignancies and persistent febrile granulocytopenia. OUTLINE: This is a randomized, double blind, multicenter study. Patients receive piperacillin/tazobactam IV over 20-30 minutes every 6 hours. Patients who become afebrile within 48-60 hours after beginning treatment continue to receive piperacillin/tazobactam alone. These afebrile patients continue treatment for a minimum of 7 days, of which 4 must be consecutive without fever. Patients who are still febrile after the initial 48-60 hours are randomized to continue on piperacillin/tazobactam alone or with vancomycin. Vancomycin IV is administered over at least 1 hour twice daily. Treatment continues for a maximum of 28 days in the absence of persistent fever. Patients are followed at 7-10 days after completion of therapy. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Enrollment
859
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium
Hopital Universitaire Erasme
Brussels, Belgium
Institut Jules Bordet
Brussels (Bruxelles), Belgium
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), Belgium
Kingston General Hospital
Kingston, Ontario, Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Masaryk University Hospital
Brno, Czechia
Turku University Central Hospital
Turku, Finland
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