Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
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ClinicalTrials.gov Identifier: NCT00137787
Recruitment Status : Unknown
Verified November 2008 by Center for Supporting Hematology-Oncology Trials. Recruitment status was: Recruiting
The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.
Condition or disease
Drug: ciprofloxacinDrug: cefepime
Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. However, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.
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Ages Eligible for Study:
15 Years to 79 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ages between 15 and 79 years
Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
Absolute neutrophil count of less than 500/microL
T-Bil level less than 2.0 times the upper limit of normal
Cre level less than 1.5 times the upper limit of normal
Written informed consent
Past history of allergic reaction to the study drug
Positive for HIV antibody
Pregnant or lactating women
Family history of auditory disturbance
Having received systemic antibacterial therapy within 14 days
Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation
No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode