Prolonged Infusion Cefepime and Nosocomial Infections
试验速览
- 阶段
- 3 期
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
详细描述
Introduction
it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (T>MIC). Although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit.
Objective
to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes.
Methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. Patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed.
Interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. The randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of SIRS criteria.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary tract infection after 48-72 hours of hospital stay
- •Respiratory tract infection after 48-72 hours of hospital stay
- •Catheter related urinary tract infection after 48-72 hours of hospital stay
- •Urinary or respiratory infections not responding to a narrower spectrum antibiotic
- •Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection
排除标准
- •Glomerular filtration rate lower than 30 ml.min/1,73m²
- •ICU admission for at least 72 hours before randomization
- •Neutrophil count lower than 1000 cels per mm³
- •Hematologic malignancy, bronchiectasis and cystic fibrosis
- •Patients allergic to cefepime
- •Concomitant treatment to another infectious disease
- •Central nervous system, cutaneous or intrabdominal infections
- •Solid organ transplantation
- •HIV with a cluster differentiation 4 (CD4) lower than 100 cels per mm³
研究组 & 干预措施
Prolonged Cefepime Infusion
Cefepime infusions should last 4 hours at least
干预措施: Prolonged Cefepime Infusion (Drug)
Usual Cefepime Infusion
Cefepime infusion should last no more than 30 minutes
干预措施: Usual Cefepime Infusion (Drug)
结局指标
主要结局
Death
时间窗: 30 days
Death in 30 days since randomization
次要结局
- Time to clinical stability(3 days)
- Duration of hospital stay(30 days since randomization)
- Death(14 days)
- Intensive care unit (ICU) admission(30 days since randomization)
- Duration of intensive care unit (ICU) stay(30 days since randomization)
- Treatment change(3 days after randomization)
- Treatment success(30 days since randomization)