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Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
This study has been completed.
First Received: September 4, 2002   Last Updated: October 8, 2007   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00044759
  Purpose

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 Intervention Phase
Hematologic Neoplasms
Drug: Piperacillin/Tazobactam (Tazocin)
Phase III

MedlinePlus related topics: Cancer Fever Lymphoma
Drug Information available for: Piperacillin sodium Piperacillin Cefepime Tazobactam Zosyn
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by Wyeth:

Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044759

  Show 36 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor, MD Wyeth
  More Information

No publications provided

Study ID Numbers: 0910B1-308
Study First Received: September 4, 2002
Last Updated: October 8, 2007
ClinicalTrials.gov Identifier: NCT00044759     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
Hematologic
Neoplasms

Study placed in the following topic categories:
Fever
Anti-Bacterial Agents
Penicillanic Acid
Cefepime
Hematologic Neoplasms
Hematologic Diseases
Tazobactam
Piperacillin
Piperacillin-tazobactam combination product
Lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Neoplasms
Hematologic Diseases
Tazobactam
Enzyme Inhibitors
Piperacillin-tazobactam combination product
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Penicillanic Acid
Therapeutic Uses
Piperacillin

ClinicalTrials.gov processed this record on May 07, 2009