Clinical trial NCT00137787: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Febrile Neutropenia
Keywords: febrile neutropenia
hematologic disease
Lead sponsor: Center for Supporting Hematology-Oncology Trials
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-08-30
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment efficacy
timeFrame: At 7 days after initiating therapy
Secondary outcomes:
measure: Treatment efficacy
timeFrame: At 21 days
measure: Toxicity
timeFrame: During the follow-up period
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Graduate School of Medicine
Study officials:
affiliation: Nagoya University
name: Yoshiko Atsuta, MD
role: STUDY_DIRECTOR
References:
citation: 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.