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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hematologic Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00044759
Pfizer
Completed
Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma

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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
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.
Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
Hematologic Neoplasms
Drug: Piperacillin/Tazobactam (Tazocin)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2003
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00044759
0910B1-308
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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