The aim of this study is to investigate whether intravenous ciprofoxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.

Condition	Intervention	Phase
Febrile Neutropenia	Drug: ciprofloxacin  Drug: cefepime	Phase III

Further Study Details: 

Primary Outcomes: Treatment efficacy at 7 days after initiating therapy
Secondary Outcomes: Time to achieve defervescence, treatment efficacy at 21 days; Toxicity
Expected Total Enrollment:  200

Infection complications during neutropenic periods are major cause 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. Ciprofoxacin 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 ciprofoxacin and cefepime for febrile neutropenic patients.

Ages Eligible for Study:  15 Years   -   79 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Hematologic disease
• Age between 15 and 79
• 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

Exclusion Criteria:

• Past history of allergic reaction to the study drug
• Positive for HIV antibody
• Pregnant or lactating woman
• 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
• On treatment with ketoprofen
• On treatment with sodium valproate
• Septic shock

Please refer to this study by ClinicalTrials.gov identifier  NCT00137787

Masamitsu Yanada, MD      81-52-741-2111  Ext. 2955    myanada@med.nagoya-u.ac.jp

Japan
      Nagoya University Graduate School of Medicine, Nagoya,  466-8550,  Japan; Recruiting

Study chairs or principal investigators

Masamitsu Yanada, MD,  Study Director,  Nagoya University Graduate School of Medicine   

Study ID Numbers:  C-SHOT 0402
Last Updated:  August 29, 2005
Record first received:  August 28, 2005
ClinicalTrials.gov Identifier:  NCT00137787
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-30