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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Febrile Neutropenia	Drug: ciprofloxacin; Drug: cefepime	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
Study Start Date :	April 2005
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	March 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: ciprofloxacin
Active Comparator: 2	Drug: cefepime

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 79 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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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

More Information

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Additional Information:

The C-SHOT homepage 

ClinicalTrials.gov Identifier:	NCT00137787 History of Changes
Other Study ID Numbers:	C-SHOT 0402
First Posted:	August 30, 2005
Last Update Posted:	November 13, 2008
Last Verified:	November 2008

Keywords provided by Center for Supporting Hematology-Oncology Trials:

febrile neutropenia; hematologic disease

Additional relevant MeSH terms:

Neutropenia; Fever; Hematologic Diseases; Febrile Neutropenia; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Ciprofloxacin; Cefepime	Cephalosporins; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors