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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137787

Enrollment

Registered

2005-08-30

Start date

2005-04-30

Completion date

2010-05-31

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia

Keywords

febrile neutropenia, hematologic disease

Brief 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.

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.

Interventions

DRUGciprofloxacin

DRUGcefepime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Treatment efficacy	At 7 days after initiating therapy

Secondary

Measure	Time frame
Treatment efficacy	At 21 days
Toxicity	During the follow-up period

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026