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临床试验/EUCTR2017-003529-13-DK
EUCTR2017-003529-13-DK招募中1 期

Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacterermia:A randomized, non-blinded, non-inferiority interventional study

Thomas Benfield0 个研究点目标入组 284 人开始时间: 2017年9月8日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
284

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Age > 18 years
  • Blood culture positive for staphylococcus aureus
  • Antibiotic treatment whit activity for S. aureus administrated within 12 hours of the first positive blood culture
  • Temperature < 37,8 ?C (100 F) at randomization
  • S. aureus negative follow-up blood culture obtained 48-120 hours after microbiological verified SAB.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 94
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 190

排除标准

  • Persistence S. aureus bacteremia before randomization ( Staph aureus positive control blood culture obtained 48-120 hours of the first positive blood culture)
  • Polymicrobial infection
  • Antibiotic treatment with no antibacterial activity for S. aureus administrated more than 12 hours of the first positive blood culture
  • Endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal echocardiography
  • Previous history of endocarditis or pacemaker/AICD infection
  • Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture.
  • Infection involving bone, joins or foreign bodies.
  • Pneumonia requiring oxygen supply at randomization.
  • S. aureus infection within the last 90 days
  • Pregnancy or breastfeeding
  • Neutropenia (blood neutrophils < 1,0 x 109/l)
  • Untreated terminal cancer
  • Chemotherapy within 30 days
  • Corticosteroid treatment (> 20mg/day prednisone or the equivalent for >14 days) within the last 30 days.
  • Ongoing treatment with immunosuppresive agents (ATC code L04A)

研究者

发起方
Thomas Benfield

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