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Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
This study has been completed.
Study NCT00044759   Information provided by Wyeth
First Received: September 4, 2002   Last Updated: October 8, 2007   History of Changes

September 4, 2002
October 8, 2007
 
 
 
 
Complete list of historical versions of study NCT00044759 on ClinicalTrials.gov Archive Site
 
 
 
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.

 
Phase III
Interventional
Treatment
Hematologic Neoplasms
Drug: Piperacillin/Tazobactam (Tazocin)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
January 2003
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00044759
 
0910B1-308
Wyeth
 
Study Director: Medical Monitor, MD Wyeth
Wyeth
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP