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Home > "H" Clinical Trials Conditions > Hematologic Neoplasms Study  Hematologic Neoplasms Study
Hematologic Neoplasms Study
For Condition: Hematologic Neoplasms
Status: Not yet recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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. - Neutropenia, defined as either < 500 absolute neutrophil count /mm3 or presentation with > 500 but < 1,000 absolute neutrophil count /mm3 when it is anticipated that counts will fall below 500/mm3 within 72 hours. (Patients will be considered evaluable for efficacy only if their absolute neutrophil count (ANC) does fall below 500/mm3). - Has not received more than one dose of an antibiotic to treat the current episode of fever. - Oral antibacterial prophylaxis must be discontinued (exception PCP prophylaxis may be continued) before the first dose of test article. - Institutional Review Board or Ethics Committee approved, signed, and dated informed consent form. If any patient is unable to give consent, it may be obtained from the patient’s next of kin or legal representative if in accordance with local laws and regulations. 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. - Death from the underlying disease expected within 14 days. - Concurrent hemodialysis, peritoneal dialysis, plasmapheresis, or hemoperfusion. - The presence of sustained sepsis syndrome, defined as systolic blood pressure < 90 mm Hg for > 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure - Identification of a specific pathogen responsible for fever before test article administration; known fungal, parasitic, or viral infection. - Microbiologically confirmed cause of a bacterial infection. - Presence of noninfectious causes of fever (eg., autoimmune connective tissue disease, chronic granulomatous disease). - Known or suspected hypersensitivity to any test articles, penicillins, cephalosporins, or beta-lactamase inhibitors - Pregnant women or nursing mothers. - Male and female patients (capable of reproducing) who do not agree to practice sexual abstinence or use an acceptable method of contraception while receiving the study drug, unless the patient is surgically or medically sterile. - Previous participation in this study. - Any investigational drugs (drugs without any Canadian Health products and Food Branch approved indications, Therapeutic Goods Administration approved indications, and Food and Drug Administration approved indications) taken within 4 weeks before administration of the first dose of test article - Patients with known human immunodeficiency virus infection
Total Enrollment:
Location and Contact Information:
Our Lady of Mercy Medical Center
Bronx, New York, 10466
United States
Sandeep Malik 718-920-9900
Health Sciences Center
Winnepeg, , R3A 1r9
Canada
Eric Bow 204-787-3964
Rochester General Hospital
Rochester, New York, 14621
United States
Zachary Kramer 716-922-4020
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Raymond Hohl 319-356-8110
UMDN/RWJ Medical School of Camden
Camden, New Jersey, 08103
United States
Annette Reboli 856-757-7767
Hamilton Health Sciences Corporation
Hamilton, ,
Canada
Coleman Rotstein 905-574-3301
Parkway Research Center, Inc.
Miami, Florida, 33169
United States
Saint Francis Hospital
Tulsa, Oklahoma, 74136
United States
Joseph Lynch 918-494-1590
Lee Hall Singletary Oncology Center
Thomasville, Georgia, 31792
United States
William Harrer 229-228-2970
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Brahm Segal 716-845-8447
Roger Williams Medical Center
Providence, Rhode Island, 02908
United States
Gerald Elfenbein 401-456-2290
Guthrie Healthcare
Sayre, Pennsylvania, 18840
United States
William Friedenberg 570-882-2134
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Elias Anaissie 501-296-1503
Northwestern University Medical School
Chicago, Illinois, 60611
United States
Gary Noskin 312-926-2729
Hospital Maisonneuve-Rosemont
Montreal, , H1T 2M4
Canada
Michel Laverdiere 514-252-3817
Berks Infectious Disease Services
West Reading, Pennsylvania, 19611
United States
Robert Jones 215-374-2214
Norris Cancer Hospital & Research Institute
Los Angeles, California, 90089
United States
Aziz Khan 323-865-3925
Royal Melbourne Hospital - Department of Clinical Haematology & Medical Oncology
Parkville, ,
Australia
Jeffery Szer 613.9342.7737
Royal University Hospital
Saskatoon, , S7N 0W8
Canada
Stephen Sanche 306-655-6658
The Ottawa Hospital
Ottawa, , K1H 8L6
Canada
Anne McCarthy 613-737-8173
University of Florida
Gainesville, Florida, 32610
United States
Shahab Khan 352-392-3000
Foundation Research
St. Petersburg, Florida, 33705
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Joanne Filicko 215-955-9504
Hackensack University Medical Center
Hackensack, New Jersey, 7601
United States
Christine Cicogna 201-996-2730
Crosier Chester Medical Center
Upland, Pennsylvania, 19013
United States
Kimberly Gerstadt 610-874-1253
West Virginia University
Morgantown, West Virginia, 26506-9162
United States
Solvieg Ericson 304-293-6859
Ocala Oncology
Ocala, Florida, 34474
United States
Thomas Cartwright 352-732-4032
University of South Carolina School of Medicine
Columbia, South Carolina, 29203
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Selina Luger 215-662-6348
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Paul Arnow 312-702-6104
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Roger Herzig 502-562-4363
Saint Joseph Hospital
Denver, Colorado, 80205
United States
Miguel Mogyoros 303-861-3652
Westchester Medical Center
Valhalla, New York, 10595
United States
University of Rochester Medical Center
Rochester, New York, 14642-8668
United States
Robert Betts 716-275-1930
The New York Hospital - Cornell Medical Center
New York City, New York, 10021
United States
Michael Schuster 212-746-6730
Medical College of Wisconsin - Froedbert Luthern Hospital
Milwaukee, Wisconsin, 53226
United States
David Vesole 414-456-6715
Additional Information:
Study ID Numbers: 0910B1-308-AU;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044759
Other Hematologic Neoplasms Studies:
1. Clofarabine in Chronic Lymphocytic Leukemia
2. A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
3. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
4. Modified Stem Cell Transplant Procedure to Treat Patients with Blood and Immune System Cancers
5. Sirolimus to Prevent GVHD after Stem Cell Transplant for Blood Cancers
Related Studies:
Other Hematologic Neoplasms Clinical Trials
Other New Jersey Clinical Trials
Other Camden Clinical Trials
Hematologic Neoplasms Study
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