Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
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.
|Bone Marrow Suppression Fever, Sweats, and Hot Flashes Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Drug: piperacillin sodium Drug: piperacillin-tazobactam Drug: tazobactam sodium Drug: vancomycin||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam|
|Study Start Date:||November 1997|
|Primary Completion Date:||June 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003805
Show 28 Study Locations
|Study Chair:||Michel P. Glauser, MD||Centre Hospitalier Universitaire Vaudois|