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

NCT00044759

Last updated date
Study Location
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

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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

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Hematologic NeoplasmsStudy Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
NCT00044759
  1. Little Rock, Arkansas
  2. Los Angeles, California
  3. Denver, Colorado
  4. Gainesville, Florida
  5. North Miami, Florida
  6. Ocala, Florida
  7. St. Petersburg, Florida
  8. Thomasville, Georgia
  9. Chicago, Illinois
  10. Chicago, Illinois
  11. Iowa City, Iowa
  12. Louisville, Kentucky
  13. Camden, New Jersey
  14. Hackensack, New Jersey
  15. Bronx, New York
  16. Buffalo, New York
  17. New York, New York
  18. Rochester, New York
  19. Rochester, New York
  20. Valhalla, New York
  21. Tulsa, Oklahoma
  22. Philadelphia, Pennsylvania
  23. Philadelphia, Pennsylvania
  24. Sayre, Pennsylvania
  25. Upland, Pennsylvania
  26. West Reading, Pennsylvania
  27. Providence, Rhode Island
  28. Columbia, South Carolina
  29. Houston, Texas
  30. Morgantown, West Virginia
  31. Milwaukee, Wisconsin
  32. Hamilton,
  33. Montreal,
  34. Ottawa,
  35. Saskatoon,
  36. Winnepeg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
Official Title  ICMJE 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
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Hematologic Neoplasms
Intervention  ICMJE Drug: Piperacillin/Tazobactam (Tazocin)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044759
Other Study ID Numbers  ICMJE 0910B1-308
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2007

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