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

Tracking Information

First Received Date ^ICMJE

August 28, 2005

Last Updated Date

November 11, 2008

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment efficacy [ Time Frame: At 7 days after initiating therapy ]

Original Primary Outcome Measures ^ICMJE

Treatment efficacy at 7 days after initiating therapy

Change History

Complete list of historical versions of study NCT00137787 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment efficacy [ Time Frame: At 21 days ]
Toxicity [ Time Frame: During the follow-up period ]

Original Secondary Outcome Measures ^ICMJE

Time to achieve defervescence, treatment efficacy at 21 days
Toxicity

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Febrile Neutropenia

Intervention ^ICMJE

Drug: ciprofloxacin
Drug: cefepime

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

March 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yoshiko Atsuta, MD	81-52-719-1973	y-atsuta@med.nagoya-u.ac.jp
Contact: Ritsuro Suzuki, MD		r-suzuki@med.nagoya-u.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00137787

Responsible Party

Study ID Numbers ^ICMJE

C-SHOT 0402

Study Sponsor ^ICMJE

Center for Supporting Hematology-Oncology Trials

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

Study Director:

Yoshiko Atsuta, MD

Nagoya University Graduate School of Medicine

Information Provided By

Center for Supporting Hematology-Oncology Trials

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP