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Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam (NCT00003805)

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.
  • Drug: piperacillin sodium
    • Drug: piperacillin-tazobactam
      • Drug: tazobactam sodium
        • Drug: vancomycin
          Ages eligible for Study
          2 Years and older
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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.

          28 locations

          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          31 October, 1997
          Updated:
          19 September, 2012
          Participants:
          859
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