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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nagoya, Japan, 466-8550
        • Nagoya University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 77 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active Comparator: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment efficacy
Time Frame: At 7 days after initiating therapy
At 7 days after initiating therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment efficacy
Time Frame: At 21 days
At 21 days
Toxicity
Time Frame: During the follow-up period
During the follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Yoshiko Atsuta, MD, Nagoya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 28, 2005

First Submitted That Met QC Criteria

August 28, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Febrile Neutropenia

Clinical Trials on ciprofloxacin

3
Subscribe