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

This study is currently recruiting participants.

Verified by Center for Supporting Hematology-Oncology Trials, November 2008

First Received: August 28, 2005 Last Updated: November 11, 2008 History of Changes

Sponsor:	Center for Supporting Hematology-Oncology Trials
Collaborator:	Bayer
Information provided by:	Center for Supporting Hematology-Oncology Trials
ClinicalTrials.gov Identifier:	NCT00137787

Purpose

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.

Condition	Intervention	Phase
Febrile Neutropenia	Drug: ciprofloxacin Drug: cefepime	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Cefepime Ciprofloxacin lactate Cefepime hydrochloride

U.S. FDA Resources

Further study details as provided by Center for Supporting Hematology-Oncology Trials:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	April 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ciprofloxacin
2: Active Comparator	Drug: cefepime

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.

Eligibility

Ages Eligible for Study:	15 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137787

Contacts

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

Locations

Japan
Nagoya University Graduate School of Medicine	Recruiting
Nagoya, Japan, 466-8550
Contact: Yoshiko Atsuta, MD 81-52-719-1973 y-atsuta@med.nagoya-u.ac.jp
Principal Investigator: Tomoki Naoe, MD

Sponsors and Collaborators

Center for Supporting Hematology-Oncology Trials

Bayer

Investigators

Study Director:

Yoshiko Atsuta, MD

Nagoya University Graduate School of Medicine

More Information

Additional Information:

The C-SHOT homepage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	C-SHOT 0402
Study First Received:	August 28, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00137787 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Center for Supporting Hematology-Oncology Trials:

febrile neutropenia
hematologic disease

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Agranulocytosis
Leukocyte Disorders
Enzyme Inhibitors
Body Temperature Changes
Pharmacologic Actions
Fever

Anti-Bacterial Agents
Neutropenia
Signs and Symptoms
Ciprofloxacin
Cefepime
Therapeutic Uses
Leukopenia
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2009