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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-46971 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| piperacillin sodium | Drug | |||
| piperacillin-tazobactam | Drug | |||
| tazobactam sodium | Drug | |||
| vancomycin | Drug |
DISEASE CHARACTERISTICS: Leukemia, lymphoma, or Hodgkin's disease OR Stem cell transplantation or bone marrow transplantation (allogenic or autologous) for a neoplastic disease Absolute granulocyte count no greater than 1,000/mm3 anticipated to fall below 500/mm3 within 24-48 hours, and expected to last for longer than 7 days from onset of fever Fever (i.e., oral or axillary temperature at least 38.5 degrees C or 101.3 degrees F once, or at least 38 degrees C or 100.4 degrees F on two or more occasions separated at least by 1 hour during a 12 hour period) Presumed infection
PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not moribund or comatose for any reason with little hope of recovery Life expectancy: At least 48 hours Hematopoietic: See Disease Characteristics Hepatic: No hepatic stupor or coma Renal: Adults: No renal failure requiring hemodialysis or peritoneal dialysis OR Creatinine no greater than 2.25 mg/dL OR Creatinine clearance at least 40 mL/min Children: No renal impairment (i.e., creatinine greater than upper limit of normal) Pulmonary: No lung infiltrate Other: No known allergy to piperacillin, tazobactam, or vancomycin No history of immediate or accelerated reaction to beta-lactam antibiotics No prior inclusion in this study No catheter related infection No known HIV infection Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 days since prior intravenous antibacterial agents Oral antibiotics for prophylaxis of bacterial infection allowed At least 30 days since prior treatment with any other investigational antibiotic No other concurrent antibiotics except trimethoprim-sulfamethoxazole for the prevention of Pneumocystis carinii pneumonia
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| Name | Affiliation | Role |
|---|---|---|
| Michel P. Glauser, MD | Centre Hospitalier Universitaire Vaudois | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States | ||
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| Boston Medical Center |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Algemeen Ziekenhuis Middelheim | Antwerp | 2020 | Belgium |
| Hopital Universitaire Erasme | Brussels | 1070 | Belgium |
| Institut Jules Bordet | Brussels (Bruxelles) | 1000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels (Bruxelles) | 1200 | Belgium |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa Regional Cancer Center - General Division | Ottawa | Ontario | K1H 8L6 | Canada |
| Masaryk University Hospital | Brno | 639 00 | Czechia |
| Turku University Central Hospital | Turku | FIN-2-0521 | Finland |
| CHR de Besancon - Hopital Saint-Jacques | Besançon | 25030 | France |
| Klinikum der Universitaet Ulm | Ulm | D-89081 | Germany |
| Hellenic Institute for Cancer-Saint Savas Hospital | Athens | 11522 | Greece |
| Athens University-Laikon General Hospital | Athens | 11527 | Greece |
| Metaxa's Memorial Cancer Hospital | Piraeus | 18537 | Greece |
| University of Patras Medical School | Rio Patras | GR-26500 | Greece |
| Wolfson Medical Center | Holon | 58100 | Israel |
| Hadassah University Hospital | Jerusalem | 91120 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| National Cancer Institute - Bratislava | Bratislava | 833 10 | Slovakia |
| St. Elizabeth Cancer Institute Hospital | Bratislava | SK-81250 | Slovakia |
| Ospedale San Giovanni | Bellinzona | CH-6500 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Universitaetsspital | Zurich | CH-8091 | Switzerland |
| Ibn-i Sina Hospital, Ankara Univeristy | Ankara | 06100 | Turkey (Türkiye) |
| Section of Infectious Diseases | Ankara | 06100 | Turkey (Türkiye) |
| Marmara University Hospital | Istanbul | 81190 | Turkey (Türkiye) |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D005334 | Fever |
| D019584 | Hot Flashes |
| D007239 | Infections |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D006689 | Hodgkin Disease |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D002051 | Burkitt Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D015470 | Leukemia, Myeloid, Acute |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D007943 | Leukemia, Hairy Cell |
| D012008 | Recurrence |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D016399 | Lymphoma, T-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
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| ID | Term |
|---|---|
| D010878 | Piperacillin |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D000078142 | Tazobactam |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010397 | Penicillanic Acid |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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