Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044759
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : October 10, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: Piperacillin/Tazobactam (Tazocin) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044759

  Show 36 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Layout table for investigator information
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Layout table for additonal information Identifier: NCT00044759     History of Changes
Other Study ID Numbers: 0910B1-308
First Posted: September 6, 2002    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action