Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Defervescence (without hypothermia)
研究概览
简要总结
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.
详细描述
OBJECTIVES:
I. The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.
OUTLINE: Patients are randomized 1 of 2 treatment arms.
All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.
ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absolute neutrophil count < 500 cells/mm^3 or < 1000 cells/mm^3 with a predicted decrease to < 500 cells/mm^3
- •Temperature > 38.0 degrees Celsius
- •Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
- •Cefepime prescribed at a dose of 2 grams IV every 8 hours
排除标准
- •Allergy to a cephalosporin antibiotic
- •Estimated creatinine clearance < 50 milliliters/minute
- •Concurrent anti-gram negative antimicrobials
- •Diagnostic criteria suggestive of sepsis
- •Circumstances which may make 3 hour infusion impractical
- •Solid tumor malignancy
研究组 & 干预措施
Arm I (standard infusion)
Patients receive cefepime hydrochloride IV over 30 minutes.
干预措施: cefepime hydrochloride (Drug)
Arm II (prolonged infusion)
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
干预措施: cefepime hydrochloride (Drug)
结局指标
主要结局
Defervescence (without hypothermia)
时间窗: 72 hours
Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model.
次要结局
- Need for additional antimicrobials(approximately 24 days)
- Mortality (in-house)(approximately 24 days)
- Clinical success or failure(approximately 24 days)
- Time to defervescence(approximately 24 days)
- Hospital length of stay(approximately 24 days)
- Successful treatment of baseline infection(approximately 24 days)