Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00044759
First received: September 4, 2002
Last updated: October 8, 2007
Last verified: October 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Neoplasms |
Drug: Piperacillin/Tazobactam (Tazocin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Piperacillin sodium
Piperacillin
Cefepime
Tazobactam
Cefepime hydrochloride
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044759
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Hide Study LocationsLocations
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Los Angeles, California, United States, 90089 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80205 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32610 | |
| North Miami, Florida, United States, 33169 | |
| Ocala, Florida, United States, 34474 | |
| St. Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| Thomasville, Georgia, United States, 31792 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40202 | |
| United States, New Jersey | |
| Camden, New Jersey, United States, 08103 | |
| Hackensack, New Jersey, United States, 7601 | |
| United States, 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 | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, 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 | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States, 02908 | |
| United States, South Carolina | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| United States, West Virginia | |
| Morgantown, West Virginia, United States, 26506-9162 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada | |
| Hamilton, Canada | |
| Montreal, Canada, H1T 2M4 | |
| Ottawa, Canada, K1H 8L6 | |
| Saskatoon, Canada, S7N 0W8 | |
| Winnepeg, Canada, R3A 1r9 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00044759 History of Changes |
| Other Study ID Numbers: | 0910B1-308 |
| Study First Received: | September 4, 2002 |
| Last Updated: | October 8, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Hematologic Neoplasms |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma Hematologic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Hematologic Diseases Piperacillin |
Cefepime Penicillanic Acid Piperacillin-tazobactam combination product Tazobactam Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013