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

Febrile Neutropenia Clinical Trial

Official title:

Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137787
• Other study ID #: C-SHOT 0402
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Est. completion date: May 2010

Study information

• Verified date: June 2018
• Source: Center for Supporting Hematology-Oncology Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Hematologic Diseases
• Neutropenia

Intervention

Drug:
• ciprofloxacin

• cefepime

Locations

Country	Name	City	State
Japan	Nagoya University Graduate School of Medicine	Nagoya

Sponsors (2)

Lead Sponsor	Collaborator
Center for Supporting Hematology-Oncology Trials	Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy		At 7 days after initiating therapy
Secondary	Treatment efficacy		At 21 days
Secondary	Toxicity		During the follow-up period

External Links

•   The C-SHOT homepage