Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
NCT ID: NCT00003805
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
859 participants
INTERVENTIONAL
1997-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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piperacillin sodium
piperacillin-tazobactam
tazobactam sodium
vancomycin
Eligibility Criteria
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Inclusion Criteria
2 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Michel P. Glauser, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Locations
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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
CHR de Besancon - Hopital Saint-Jacques
Besançon, , France
Klinikum der Universitaet Ulm
Ulm, , Germany
Hellenic Institute for Cancer-Saint Savas Hospital
Athens, , Greece
Athens University-Laikon General Hospital
Athens, , Greece
Metaxa's Memorial Cancer Hospital
Piraeus, , Greece
University of Patras Medical School
Rio Patras, , Greece
Wolfson Medical Center
Holon, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
National Cancer Institute - Bratislava
Bratislava, , Slovakia
St. Elizabeth Cancer Institute Hospital
Bratislava, , Slovakia
Ospedale San Giovanni
Bellinzona, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Universitaetsspital
Zurich, , Switzerland
Ibn-i Sina Hospital, Ankara Univeristy
Ankara, , Turkey (Türkiye)
Section of Infectious Diseases
Ankara, , Turkey (Türkiye)
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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Other Identifiers
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EORTC-46971
Identifier Type: -
Identifier Source: secondary_id
EORTC-46971
Identifier Type: -
Identifier Source: org_study_id
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