Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Supporting Hematology-Oncology Trials
• Collaborator: Bayer
• Treatments: Cefepime; Cephalosporins; Ciprofloxacin

Criteria

Inclusion Criteria:

• Hematologic disease

• 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

Exclusion Criteria:

• 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

• On treatment with ketoprofen

• On treatment with sodium valproate

• Septic shock