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

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

Tracking Information

• First Submitted Date: August 28, 2005
• First Posted Date: August 30, 2005
• Last Update Posted Date: June 26, 2018
• Actual Study Start Date: April 2005
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 21, 2007): Treatment efficacy [ Time Frame: At 7 days after initiating therapy ]
• Original Primary Outcome Measures (submitted: August 28, 2005): Treatment efficacy at 7 days after initiating therapy

Current Secondary Outcome Measures (submitted: June 21, 2007)

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

Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Febrile Neutropenia

Intervention

• Drug: ciprofloxacin
• Drug: cefepime

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 25, 2018): 51
• Original Enrollment (submitted: August 28, 2005): 200
• Actual Study Completion Date: May 2010
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 79 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00137787
• Other Study ID Numbers: C-SHOT 0402
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Center for Supporting Hematology-Oncology Trials
• Study Sponsor: Center for Supporting Hematology-Oncology Trials
• Collaborators: Bayer

Investigators

• Study Director: Yoshiko Atsuta, MD; Nagoya University

• PRS Account: Center for Supporting Hematology-Oncology Trials
• Verification Date: June 2018