- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137787
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
June 25, 2018 updated by: Center for Supporting Hematology-Oncology Trials
Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nagoya, Japan, 466-8550
- Nagoya University Graduate School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 77 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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Active Comparator: 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment efficacy
Time Frame: At 7 days after initiating therapy
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At 7 days after initiating therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment efficacy
Time Frame: At 21 days
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At 21 days
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Toxicity
Time Frame: During the follow-up period
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During the follow-up period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Yoshiko Atsuta, MD, Nagoya University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2005
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 28, 2005
First Submitted That Met QC Criteria
August 28, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 25, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Body Temperature Changes
- Heat Stress Disorders
- Neutropenia
- Hematologic Diseases
- Hyperthermia
- Fever
- Febrile Neutropenia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Ciprofloxacin
- Cefepime
Other Study ID Numbers
- C-SHOT 0402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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