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

Center for Supporting Hematology-Oncology Trials

Status and phase

Completed

Phase 3

Conditions

Febrile Neutropenia

Treatments

Drug: ciprofloxacin

Drug: cefepime

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00137787

C-SHOT 0402

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

15 to 79 years old

Volunteers

No Healthy Volunteers

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