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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Center for Supporting Hematology-Oncology Trials.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Center for Supporting Hematology-Oncology Trials
ClinicalTrials.gov Identifier:
NCT00137787
First received: August 28, 2005
Last updated: November 11, 2008
Last verified: November 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Resource links provided by NLM:

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
Experimental: 1 Drug: ciprofloxacin
Active Comparator: 2 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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

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

ClinicalTrials.gov Identifier: NCT00137787     History of Changes
Other Study ID Numbers: C-SHOT 0402 
Study First Received: August 28, 2005
Last Updated: November 11, 2008
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:
Neutropenia
Fever
Hematologic Diseases
Febrile Neutropenia
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

ClinicalTrials.gov processed this record on September 29, 2016