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Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 1, 1997
Primary Completion Date
June 1, 2000
Last Updated
September 24, 2012
859
ACTUAL participants
piperacillin sodium
DRUG
piperacillin-tazobactam
DRUG
tazobactam sodium
DRUG
vancomycin
DRUG
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
NCT05488340
NCT06650501
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06237452