Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
干预措施: ciprofloxacin (Drug)
2
干预措施: cefepime (Drug)
结局指标
主要结局
Treatment efficacy
时间窗: At 7 days after initiating therapy
次要结局
- Toxicity(During the follow-up period)
- Treatment efficacy(At 21 days)