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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

Tracking Information
First Submitted Date  ICMJE August 28, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date June 26, 2018
Actual Study Start Date  ICMJE April 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
Treatment efficacy [ Time Frame: At 7 days after initiating therapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2005)
Treatment efficacy at 7 days after initiating therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
  • Treatment efficacy [ Time Frame: At 21 days ]
  • Toxicity [ Time Frame: During the follow-up period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2005)
  • Time to achieve defervescence, treatment efficacy at 21 days
  • Toxicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Official Title  ICMJE Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Febrile Neutropenia
Intervention  ICMJE
  • Drug: ciprofloxacin
  • Drug: cefepime
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: ciprofloxacin
  • Active Comparator: 2
    Intervention: Drug: cefepime
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2018)
51
Original Enrollment  ICMJE
 (submitted: August 28, 2005)
200
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137787
Other Study ID Numbers  ICMJE C-SHOT 0402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Center for Supporting Hematology-Oncology Trials
Study Sponsor  ICMJE Center for Supporting Hematology-Oncology Trials
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Yoshiko Atsuta, MD Nagoya University
PRS Account Center for Supporting Hematology-Oncology Trials
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP