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

October 8, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Hamilton, Canada
      • Montreal, Canada, H1T 2M4
      • Ottawa, Canada, K1H 8L6
      • Saskatoon, Canada, S7N 0W8
      • Winnepeg, Canada, R3A 1r9
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Los Angeles, California, United States, 90089
    • Colorado
      • Denver, Colorado, United States, 80205
    • Florida
      • Gainesville, Florida, United States, 32610
      • North Miami, Florida, United States, 33169
      • Ocala, Florida, United States, 34474
      • St. Petersburg, Florida, United States, 33705
    • Georgia
      • Thomasville, Georgia, United States, 31792
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • Hackensack, New Jersey, United States, 7601
    • 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
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
    • 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
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Texas
      • Houston, Texas, United States, 77030
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9162
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

January 1, 2003

Study Registration Dates

First Submitted

September 4, 2002

First Submitted That Met QC Criteria

September 5, 2002

First Posted (ESTIMATE)

September 6, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 8, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910B1-308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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