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

Phase 3

Completed

• Conditions: Febrile Neutropenia
• Interventions: Drug: cefepime; Drug: ciprofloxacin

• Registration Number: NCT00137787
• Lead Sponsor: Center for Supporting Hematology-Oncology Trials

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-28
• Study First Submitted QC: 2005-08-28
• Study First Posted: 2005-08-30
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	cefepime	-
1	ciprofloxacin	-

Primary Outcome Measures

Name	Time	Method
Treatment efficacy	At 7 days after initiating therapy

Secondary Outcome Measures

Name	Time	Method
Toxicity	During the follow-up period
Treatment efficacy	At 21 days

Trial Locations

Locations (1)

Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan