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

NCT ID: NCT00137787

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-05-31

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.

Conditions

Febrile Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

ciprofloxacin

Intervention Type: DRUG

2

Group Type: ACTIVE_COMPARATOR

cefepime

Intervention Type: DRUG

Interventions

ciprofloxacin

Intervention Type: DRUG

cefepime

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Center for Supporting Hematology-Oncology Trials

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshiko Atsuta, MD

Role: STUDY_DIRECTOR

Nagoya University

Locations

Nagoya University Graduate School of Medicine

Nagoya, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 23317527 (View on PubMed)

Other Identifiers

C-SHOT 0402

Identifier Type: -

Identifier Source: org_study_id