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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Hematologic Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

0910B1-308

NCT ID:

NCT00044759

Start Date:

Completion Date:

January 2003

Related Keywords:

  • Hematologic Neoplasms
  • Hematologic
  • Neoplasms
  • Neoplasms
  • Lymphoma
  • Hematologic Neoplasms

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Louisville, Kentucky  40207
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Denver, Colorado  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Tulsa, Oklahoma  
Charleston, West Virginia  25304
Providence, Rhode Island  02908