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

Condition(s) targeted: Febrile Neutropenia

Intervention: ciprofloxacin (Drug); cefepime (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Center for Supporting Hematology-Oncology Trials

Official(s) and/or principal investigator(s):
Masamitsu Yanada, MD, Study Director, Affiliation: Nagoya University Graduate School of Medicine

Overall contact:
Masamitsu Yanada, MD, Phone: 81-52-741-2111, Ext: 2955, Email: myanada@med.nagoya-u.ac.jp

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.

Official title: Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Treatment efficacy

Secondary outcome:

Treatment efficacy

Toxicity

Detailed description: 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.

Minimum age: 15 Years. Maximum age: 79 Years. Gender(s): Both.

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

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

Nagoya University Graduate School of Medicine, Nagoya 466-8550, Japan; Recruiting
Masamitsu Yanada, MD, Phone: 81-52-741-2111, Ext: 2955, Email: myanada@med.nagoya-u.ac.jp
Tomoki Naoe, MD, Principal Investigator
Masamitsu Yanada, MD, Sub-Investigator

The C-SHOT homepage

Starting date: April 2005
Ending date: March 2010
Last updated: May 5, 2008