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

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ClinicalTrials.gov Identifier: NCT00044759
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : October 10, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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

Study Design
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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

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00044759


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles, California, United States, 90089
United States, Colorado
Denver, Colorado, United States, 80205
United States, Florida
Gainesville, Florida, United States, 32610
North Miami, Florida, United States, 33169
Ocala, Florida, United States, 34474
St. Petersburg, Florida, United States, 33705
United States, Georgia
Thomasville, Georgia, United States, 31792
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, New Jersey
Camden, New Jersey, United States, 08103
Hackensack, New Jersey, United States, 7601
United States, New York
Bronx, New York, United States, 10466
Buffalo, New York, United States, 14263
New York, New York, United States, 10021
Rochester, New York, United States, 14621
Rochester, New York, United States, 14642-8668
Valhalla, New York, United States, 10595
United States, Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Sayre, Pennsylvania, United States, 18840
Upland, Pennsylvania, United States, 19013
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Providence, Rhode Island, United States, 02908
United States, South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Houston, Texas, United States, 77030
United States, West Virginia
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada
Hamilton, Canada
Montreal, Canada, H1T 2M4
Ottawa, Canada, K1H 8L6
Saskatoon, Canada, S7N 0W8
Winnepeg, Canada, R3A 1r9
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00044759    
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:
Hematologic
Neoplasms
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Tazobactam
Piperacillin
 Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action