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
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