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

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ClinicalTrials.gov Identifier: NCT00137787
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Center for Supporting Hematology-Oncology Trials

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)
Actual Enrollment : 51 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
Actual Study Start Date : April 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137787


Locations
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Japan
Nagoya University Graduate School of Medicine
Nagoya, Japan, 466-8550
Sponsors and Collaborators
Center for Supporting Hematology-Oncology Trials
Bayer
Investigators
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Study Director: Yoshiko Atsuta, MD Nagoya University
More Information
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Publications of Results:

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Responsible Party: Center for Supporting Hematology-Oncology Trials
ClinicalTrials.gov Identifier: NCT00137787    
Other Study ID Numbers: C-SHOT 0402
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Center for Supporting Hematology-Oncology Trials:
febrile neutropenia
hematologic disease
Additional relevant MeSH terms:
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Neutropenia
Hematologic Diseases
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Body Temperature Changes
Signs and Symptoms
Ciprofloxacin
 Cefepime
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