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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematologic Neoplasms

Intervention: Piperacillin/Tazobactam (Tazocin) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer


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.

Clinical Details

Official title: A Randomized, Open-Label, Multi-Center, Comparative Study of the Efficacy and Safety of Piperacillin/Tazobactam to Cefepime for the Empiric Treatment of Neutropenic Fever in Patients With a Hematologic Malignancy or Lymphoma

Study design: Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Hamilton, Canada

Montreal H1T 2M4, Canada

Ottawa K1H 8L6, Canada

Saskatoon S7N 0W8, Canada

Winnepeg R3A 1r9, Canada

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Additional Information

Last updated: October 8, 2007

Page last updated: August 23, 2015

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