Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam
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.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Michel P. Glauser, MD
Study Chair
Centre Hospitalier Universitaire Vaudois
United States: Federal Government
EORTC-46971
NCT00003805
November 1997
Name | Location |
---|---|
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Boston Medical Center | Boston, Massachusetts 02118 |