Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2005
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 26, 2018
June 1, 2018
4.7 years
August 28, 2005
June 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment efficacy
At 7 days after initiating therapy
Secondary Outcomes (2)
Treatment efficacy
At 21 days
Toxicity
During the follow-up period
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Center for Supporting Hematology-Oncology Trialslead
- Bayercollaborator
Study Sites (1)
Nagoya University Graduate School of Medicine
Nagoya, 466-8550, Japan
Related 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 Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.
PMID: 23317527RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yoshiko Atsuta, MD
Nagoya University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2005
First Posted
August 30, 2005
Study Start
April 1, 2005
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
June 26, 2018
Record last verified: 2018-06