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临床试验/NCT00548002
NCT00548002已完成不适用

Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

University of Helsinki1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 1999年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
430
试验地点
1
主要终点
Case fatality rate

研究概览

简要总结

To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.

排除标准

  • age younger than 18 years
  • imprisonment
  • proven or suspected pregnancy
  • breastfeeding, epilepsy
  • another bacteremia during the previous 28 days
  • polymicrobial bacteremia (_>3 microbes)
  • history of allergy to any quinolone antibiotic
  • previous tendinitis during fluoroquinolone therapy
  • prior fluoroquinolone use for more than 5 days before randomization
  • positive culture for Staphylococcus aureus only from a central intravenous catheter
  • neutropenia (<0.5 x 109/L) or failure to supply an informed consent
  • patients with bacteremia due to methicillin-resistant S. aureus and a S. aureus strain resistant to any fluoroquinolone
  • patients with meningitis at the time of randomization

研究组 & 干预措施

1 and 2

Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).

干预措施: trovafloxacin and levofloxacin (Drug)

结局指标

主要结局

Case fatality rate

时间窗: At 28 days and at 3 months

次要结局

  • The number of complications (e.g. deep infections) observed after the first week antibiotic treatment, decrease in serum C-reactive protein concentration, length of antibiotic treatment, need for surgical intervention, and time to defervescence.(3 months)

研究者

申办方类型
Other

研究点 (1)

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