Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia (NCT00020865) | Clinical Trial Compass
UnknownPhase 3
Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia
United StatesStarted 2001-09
Plain-language summary
RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of neutropenia in patients who are being treated for cancer. It is not yet known whether levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of neutropenia.
PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being treated for cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS: Diagnosis of malignancy Solid tumor (including lymphoma) or leukemia Hospitalized and anticipated to remain hospitalized during study Febrile defined as oral temperature of at least 100.4 degrees F (38 degrees C) on 2 occasions within 24 hours OR at least 100.8 degrees F (38.2 degrees C) on a single reading No obvious noninfectious cause of fever (e.g., platelet transfusion) Neutropenic, defined as absolute neutrophil count (ANC) currently less than 500/mm3 OR anticipated to be less than 500/mm3 within 24 hours of study entry Anticipated ANC to be less than 500/mm3 for at least 72 hours No neutropenia unassociated with malignancy No chronic neutropenia No neutropenia anticipated to last more than 14 days No acute myelogenous leukemia unless receiving consolidation chemotherapy or induction dose that does not prolong neutropenia for more than 3 weeks No infection due to an identified organism No high likelihood of infection due to anaerobic organisms, including intra-abdominal infections or perirectal abscess at admission No known osteomyelitis No requirement for new antifungal agent
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: At least 14 days Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Creatinine clearance at least 20 mL/min No oliguria (urine output less than 20 mL/hour) unresponsive to fluid challenge Cardiovascular: No shock or hypotension (supine systolic blood pressure…