To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered
intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for
the empiric treatment of neutropenic fever in patients with a hematologic malignancy or
lymphoma.
Inclusion Criteria:
- Hospitalized male and female patients, 18 years of age or older
- Patients who have leukemia (acute lymphocytic leukemia [ALL], acute myelogenous
leukemia [AML], chronic lymphocytic leukemia [CLL], chronic myelogenous leukemia
[CML]), that is newly diagnosed, who have had initial induction, re-induction, or
intensification chemotherapy or who have had a bone marrow (allogenic, syngeneic, or
autologous) or peripheral blood stem-cell transplant OR Patients with lymphoma,
Hodgkin's disease, multiple myeloma, myelodysplastic syndrome or myelodysplasia
(refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS],
refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in
transformation to leukemia [RAEB-T], or chronic myelomonocytic leukemia [CMML].
- Fever, defined as an oral temperature of ≥ 37. 9°C /100. 2°F, a rectal temperature ≥
38. 4°C /101. 4°F, or a tympanic temperature ≥ 38°C /100. 4°F
Exclusion Criteria:
- The presence of any clinically acute or chronic disease or condition that, in the
opinion of the investigator, may interfere with the patient's ability to safely
comply with the conditions of the protocol, or could preclude the evaluation of the
patient's response or could make the completion of the therapy unlikely
- Neutropenia associated with syndromes that are not associated with a high risk of
bacterial infection (eg. chronic benign neutropenia or Kostmann's syndrome)
- Neutropenia due to primary bone marrow failure
Hamilton, Canada
Montreal H1T 2M4, Canada
Ottawa K1H 8L6, Canada
Saskatoon S7N 0W8, Canada
Winnepeg R3A 1r9, Canada
Little Rock, Arkansas 72205, United States
Los Angeles, California 90089, United States
Denver, Colorado 80205, United States
Gainesville, Florida 32610, United States
North Miami, Florida 33169, United States
Ocala, Florida 34474, United States
St. Petersburg, Florida 33705, United States
Thomasville, Georgia 31792, United States
Chicago, Illinois 60611, United States
Chicago, Illinois 60637, United States
Iowa City, Iowa 52242, United States
Louisville, Kentucky 40202, United States
Camden, New Jersey 08103, United States
Hackensack, New Jersey 7601, United States
Bronx, New York 10466, United States
Buffalo, New York 14263, United States
New York, New York 10021, United States
Rochester, New York 14621, United States
Rochester, New York 14642-8668, United States
Valhalla, New York 10595, United States
Tulsa, Oklahoma 74136, United States
Philadelphia, Pennsylvania 19104, United States
Philadelphia, Pennsylvania 19107, United States
Sayre, Pennsylvania 18840, United States
Upland, Pennsylvania 19013, United States
West Reading, Pennsylvania 19611, United States
Providence, Rhode Island 02908, United States
Columbia, South Carolina 29203, United States
Houston, Texas 77030, United States
Morgantown, West Virginia 26506-9162, United States
Milwaukee, Wisconsin 53226, United States
