Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma

Completed · Phase 3

Conditions studied: Hematologic Neoplasms

In brief

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.

Key facts

Study ID

NCT00044759

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

Expected to finish

2003-01-01

Last updated by the study team

2007-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Thomasville, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Camden, New Jersey, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sayre, Pennsylvania, United States
• Study site — Upland, Pennsylvania, United States

Full record on ClinicalTrials.gov

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