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

Center for Supporting Hematology-Oncology Trials51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Febrile Neutropenia

Interventions

ciprofloxacinDRUG

cefepimeDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Nagoya University Graduate School of Medicine

Nagoya, Japan

Outcomes

Primary Outcomes

Treatment efficacy

Time frame: At 7 days after initiating therapy

Secondary Outcomes

Treatment efficacy

Time frame: At 21 days

Toxicity

Time frame: During the follow-up period

Data from ClinicalTrials.gov

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