Efficacy of Seven and Fourteen Days of Antibiotic Treatment in Uncomplicated Staphylococcus Aureus Bacteremia: A Randomized, Non-blinded, Non-inferiority Interventional Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- 90-day survival without clinical or microbiological failure to treatment or relapse
研究概览
简要总结
Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course antibiotic therapy. Current international guidelines recommend fourteen days of intravenous antibiotic treatment for SAB in order to minimize risks of secondary deep infections and complications. However, patients with simple SAB are known to have a low risk of complications. Reducing treatment length in uncomplicated SAB would reduce the total consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to determine if seven days of antibiotic treatment in patients with uncomplicated SAB is non-inferior to fourteen days of treatment.
Method: The study is designed as a randomized, non-blinded, non-inferiority interventional study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve weeks after termination of antibiotic treatment. As a measure of secondary outcome the prevalence of severe adverse effects will be evaluated, in particular secondary infection with Clostridium difficile, mortality as well as public health related costs. Patients identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a statistical non-inferiority margin of 10%.
Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with uncomplicated SAB is sufficient and safe, potentially modifying current treatment recommendations.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Blood culture positive for Staphylococcus aureus
- •Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12 hours of the first positive blood culture
- •Temperature < 37,5 degrees celsius at randomization
- •S. aureus negative follow-up blood culture obtained 48-96 hours after microbiological verified SAB.
- •Patients written consent obtained
排除标准
- •Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-96 hours of the first positive blood culture)
- •Polymicrobial infection
- •Antibiotic treatment whit no antimicrobial activity to 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
- •Pacemaker or other intracardiac implant
- •Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture.
- •Prosthetics in joints and bones or vascular grafts
- •Pneumonia or infection involving bone or joints
- •Previously bone/join infection
- •S. aureus infection within the last 90 days
- •Pregnancy or breastfeeding
- •Neutropenia (blood neutrophils < 1,0 x 109/l)
- •Untreated cancer
- •Chemotherapy within 90 days.
研究组 & 干预措施
Antibiotic therapy duration for 7 days
干预措施: Antibiotic therapy duration for 7 days (Drug)
结局指标
主要结局
90-day survival without clinical or microbiological failure to treatment or relapse
时间窗: up to 90 days
次要结局
- Mortality(Days 14, 28, 90 and 180)
- Acute renal injury(Up to 26 weeks)
- Clostridium difficile infection(Up to 26 weeks)
- Microbiologically failure to treatment(less than 7 days after treatment termination)
- Microbiologically relapse(more than 7 days after treatment termination)
- Clinical failure to treatment or relapse(Up to day 90)
- Severe adverse events(Up to 26 weeks)
- Multidrug-resistance organism(Up to 26 weeks)
- Health-associated costs(Up to 26 weeks)
研究者
Thomas Benfield
Clinical Professor
Hvidovre University Hospital