2024-519186-21-01招募中4 期
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
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 8
- 主要终点
- 90-day survival without clinical or microbiological failure to treatment or relapse in patients treated with 7 days versus 14 days of antibiotic therapy
研究概览
简要总结
To compare 7 and 14 days of antibiotic treatment in patients with uncomplicated SAB in terms of mortality and the prevalence of microbiological and clinical failure to treat and recurrence within 90 days of diagnosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 < 37,8 ᵒC (100°F) at randomization
- •S. aureus negative follow-up blood culture obtained 48-120 hours after microbiological verified SAB
排除标准
- •Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-120 hours of the first positive blood culture)
- •Pregnancy or breastfeeding
- •Neutropenia (blood neutrophils < 1,0 x 109/l)
- •Untreated terminal cancer
- •Chemotherapy within 30 days
- •Corticosteroid treatment (> 20 mg/day prednisone or the equivalent for > 14 days) within the last 30 days
- •Ongoing treatment with immunosuppressive agents (ATC code L04A)
- •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 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, joints or foreign bodies
- •Pneumonia requiring oxygen supply at randomization
- •S. aureus infection within the last 90 days
结局指标
主要结局
90-day survival without clinical or microbiological failure to treatment or relapse in patients treated with 7 days versus 14 days of antibiotic therapy
90-day survival without clinical or microbiological failure to treatment or relapse in patients treated with 7 days versus 14 days of antibiotic therapy
次要结局
- All-cause mortality days 14, 28, 90 and 180
- Microbiological failure to treatment
- Microbiological relapse
- Clinical failure to treatment
- Severe adverse events grade ≥3
- Clostridium difficile infection
- Multidrug-resistance organism
- Health-associated costs associated the treatment lengths
- Desirability of outcome ranking (DOOR)
- Hospital admissions during follow up
研究者
Thomas Benfield
Scientific
Hvidovre Hospital
研究点 (8)
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