Hematologic NeoplasmsPhase 3NCT00044759
Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma
A Phase 3 study testing Piperacillin/Tazobactam (Tazocin) in people with Hematologic Neoplasms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 36 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Piperacillin/Tazobactam (Tazocin)
- How many people
- Not given
- Where
- 36 sitesin 2 countries
- Study dates
- Start not givento Jan 2003
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States31 sites
Study site
Buffalo, New York, 14263
Study site
Camden, New Jersey, 08103
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60637
Study site
Columbia, South Carolina, 29203
Study site
Denver, Colorado, 80205
Study site
Gainesville, Florida, 32610
Study site
Hackensack, New Jersey, 7601
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90089
Study site
Louisville, Kentucky, 40202
Study site
Milwaukee, Wisconsin, 53226
Study site
Morgantown, West Virginia, 26506-9162
Study site
New York, New York, 10021
Study site
North Miami, Florida, 33169
Study site
Ocala, Florida, 34474
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Providence, Rhode Island, 02908
Study site
Rochester, New York, 14621
Study site
Rochester, New York, 14642-8668
Study site
Sayre, Pennsylvania, 18840
Study site
St. Petersburg, Florida, 33705
Study site
The Bronx, New York, 10466
Study site
Thomasville, Georgia, 31792
Study site
Tulsa, Oklahoma, 74136
Study site
Upland, Pennsylvania, 19013
Study site
Valhalla, New York, 10595
Study site
West Reading, Pennsylvania, 19611
Canada5 sites
Study site
Hamilton
Study site
Montreal, H1T 2M4
Study site
Ottawa, K1H 8L6
Study site
Saskatoon, S7N 0W8
Study site
Winnepeg, R3A 1r9
About this study
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
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.
- Conditions
- Hematologic Neoplasms
- Being tested
- Piperacillin/Tazobactam (Tazocin)
- Keywords
- Hematologic, Neoplasms
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/Tazobactam (Tazocin)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2002 (estimated)
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044759
- Sponsor's protocol ID
- 0910B1-308
- Status last verified
- Oct 2007
- First submitted
- 4 Sep 2002
- Last updated
- 10 Oct 2007
- Results posted
- No