Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Information source: Center for Supporting Hematology-Oncology Trials
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Febrile Neutropenia
Intervention: ciprofloxacin (Drug); cefepime (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Center for Supporting Hematology-Oncology Trials Official(s) and/or principal investigator(s): Yoshiko Atsuta, MD, Study Director, Affiliation: Nagoya University
Overall contact: Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp
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.
Clinical Details
Official title: Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment efficacy
Secondary outcome: Treatment efficacyToxicity
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
Minimum age: 15 Years.
Maximum age: 79 Years.
Gender(s): Both.
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
Locations and Contacts
Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp
Nagoya University Graduate School of Medicine, Nagoya 466-8550, Japan; Recruiting Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp Tomoki Naoe, MD, Principal Investigator
Additional Information
The C-SHOT homepage
Starting date: April 2005
Last updated: November 11, 2008
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