Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: ciprofloxacin
* Drug: cefepime


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ciprofloxacin<br> <br> |
| Active Comparator: 2<br> | Drug: cefepime<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy |  | At 7 days after initiating therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy |  | At 21 days | 
| Toxicity |  | During the follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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febrile neutropenia, hematologic disease