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

NCT ID: NCT00044759

Last Updated: 2007-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematologic Neoplasms

Keywords

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Hematologic Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Piperacillin/Tazobactam (Tazocin)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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Gainesville, Florida, United States

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North Miami, Florida, United States

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Ocala, Florida, United States

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St. Petersburg, Florida, United States

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Thomasville, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Camden, New Jersey, United States

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Hackensack, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Upland, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Houston, Texas, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Hamilton, , Canada

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Montreal, , Canada

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Ottawa, , Canada

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Saskatoon, , Canada

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Winnepeg, , Canada

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Countries

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United States Canada

Other Identifiers

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0910B1-308

Identifier Type: -

Identifier Source: org_study_id