Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
- Conditions
- Bone Marrow SuppressionFever, Sweats, and Hot FlashesInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00003805
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 859
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Universitaetsspital
🇨🇭Zurich, Switzerland
Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Turku University Central Hospital
🇫🇮Turku, Finland
Wolfson Medical Center
🇮🇱Holon, Israel
CHR de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Institut Jules Bordet
🇧🇪Brussels (Bruxelles), Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels (Bruxelles), Belgium
Masaryk University Hospital
🇨🇿Brno, Czech Republic
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Metaxa's Memorial Cancer Hospital
🇬🇷Piraeus, Greece
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Hellenic Institute for Cancer-Saint Savas Hospital
🇬🇷Athens, Greece
Athens University-Laikon General Hospital
🇬🇷Athens, Greece
University of Patras Medical School
🇬🇷Rio Patras, Greece
Ibn-i Sina Hospital, Ankara Univeristy
🇹🇷Ankara, Turkey
Section of Infectious Diseases
🇹🇷Ankara, Turkey
Marmara University Hospital
🇹🇷Istanbul, Turkey
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Klinikum der Universitaet Ulm
🇩🇪Ulm, Germany
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Chaim Sheba Medical Center
🇮🇱Ramat-Gan, Israel
St. Elizabeth Cancer Institute Hospital
🇸🇰Bratislava, Slovakia