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

Primary Purpose

Febrile Neutropenia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ciprofloxacin
cefepime
Sponsored by
Center for Supporting Hematology-Oncology Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Febrile Neutropenia focused on measuring febrile neutropenia, hematologic disease

Eligibility Criteria

15 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Treatment efficacy

Secondary Outcome Measures

Treatment efficacy
Toxicity

Full Information

First Posted
August 28, 2005
Last Updated
June 25, 2018
Sponsor
Center for Supporting Hematology-Oncology Trials
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00137787
Brief Title
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Official Title
Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2005 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Supporting Hematology-Oncology Trials
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia
Keywords
febrile neutropenia, hematologic disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
cefepime
Primary Outcome Measure Information:
Title
Treatment efficacy
Time Frame
At 7 days after initiating therapy
Secondary Outcome Measure Information:
Title
Treatment efficacy
Time Frame
At 21 days
Title
Toxicity
Time Frame
During the follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiko Atsuta, MD
Organizational Affiliation
Nagoya University
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya University Graduate School of Medicine
City
Nagoya
ZIP/Postal Code
466-8550
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23317527
Citation
Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.
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Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

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