Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Clinical outcome of infants
研究概览
简要总结
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus.
The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.
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
- 4 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.
排除标准
- •previous treatment with vancomycin during the week before,
- •infants referred from other hospitals and, upon admission, were being treated with antibiotics.
研究组 & 干预措施
Cefazolin group
Initial empirical treatment with cefazolin and amikacin
干预措施: Cefazolin (Drug)
Cefazolin group
Initial empirical treatment with cefazolin and amikacin
干预措施: Amikacin (Drug)
Vancomycin
Initial empirical treatment with vancomycin and amikacin
干预措施: Vancomycin (Drug)
Vancomycin
Initial empirical treatment with vancomycin and amikacin
干预措施: Amikacin (Drug)
结局指标
主要结局
Clinical outcome of infants
时间窗: Seven to ten days after starting antibiotics
Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria: Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment. Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis.
次要结局
- Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.(Within 72 hours of starting treatment)
研究者
Jose Ceriani Cernadas M.D.
M.D.
Hospital Italiano de Buenos Aires