Status:
COMPLETED
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Lead Sponsor:
Center for Supporting Hematology-Oncology Trials
Collaborating Sponsors:
Bayer
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
15-79 years
Phase:
PHASE3
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 warr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00137787
Start Date
April 1 2005
End Date
May 1 2010
Last Update
June 26 2018
Active Locations (1)
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1
Nagoya University Graduate School of Medicine
Nagoya, Japan, 466-8550