Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
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
1 other identifier
interventional
N/A
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2002
CompletedFirst Posted
Study publicly available on registry
September 6, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedOctober 10, 2007
October 1, 2007
September 4, 2002
October 8, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Little Rock, Arkansas, 72205, United States
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Los Angeles, California, 90089, United States
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Denver, Colorado, 80205, United States
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Gainesville, Florida, 32610, United States
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North Miami, Florida, 33169, United States
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Ocala, Florida, 34474, United States
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St. Petersburg, Florida, 33705, United States
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Thomasville, Georgia, 31792, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60637, United States
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Iowa City, Iowa, 52242, United States
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Louisville, Kentucky, 40202, United States
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Camden, New Jersey, 08103, United States
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Hackensack, New Jersey, 7601, United States
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Buffalo, New York, 14263, United States
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New York, New York, 10021, United States
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Rochester, New York, 14621, United States
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Rochester, New York, 14642-8668, United States
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The Bronx, New York, 10466, United States
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Valhalla, New York, 10595, United States
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Tulsa, Oklahoma, 74136, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Sayre, Pennsylvania, 18840, United States
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Upland, Pennsylvania, 19013, United States
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West Reading, Pennsylvania, 19611, United States
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Providence, Rhode Island, 02908, United States
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Columbia, South Carolina, 29203, United States
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Houston, Texas, 77030, United States
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Morgantown, West Virginia, 26506-9162, United States
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Milwaukee, Wisconsin, 53226, United States
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Hamilton, Canada
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Montreal, H1T 2M4, Canada
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Ottawa, K1H 8L6, Canada
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Saskatoon, S7N 0W8, Canada
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Winnepeg, R3A 1r9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
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