Effect of Single-dose Vancomycin After Catheter Replacement for Suspected Central Line-associated Bloodstream Infection (CLABSI) on Resolution of Infection in Critically Ill Patients: A Single Center Randomized Open Label Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Resolution of infection
研究概览
简要总结
Randomized controlled trial of the effect of a single-dose intravenous Vancomycin after catheter replacement for suspected central line-associated bloodstream infection on resolution of infection in critically ill patients.
详细描述
Patients on the local intensive care unit with suspicion of central line-associated bloodstream infection will be randomized to standard of care consisting of catheter replacement and blood and catheter tip cultures and to standard of care plus a single-dose vancomycin. The effect of the intervention on resolution of humoral inflammation and negativity of blood cultures will be assessed after 48 and 96 hours.
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
- •Suspected central line-associated bloodstram infection defined as:
- •Catheterization with a non-tunneled CVC and
- •Clinical signs of local catheter infection or any increase in humoral inflammatory markers (PCT, CRP, WBC) or elevated body temperature ≥ 38.3°C not otherwise explained.
- •Baseline CRP at screening ≥ 100 mg/L
排除标准
- •known positive blood cultures at the time of randomization
- •High risk situation warranting immediate empiric antibiotic therapy:
- •endovascular implant (prosthetic valve, pacemaker, vascular graft)
- •high-risk for endocarditis warranting endocarditis-prophylaxis
- •Septic shock
- •Catheter replacement not feasible or no further indication for central venous catheterization
- •Known hypersensitivity to vancomycin or any component of the formulation.
- •Administration of Vancomycin, Teicoplanin, Daptomycin or Linezolid <48 hours before enrolment.
- •Enrolment in another clinical study
- •Pregnancy
研究组 & 干预措施
Intervention
Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg
干预措施: Vancomycin (Drug)
结局指标
主要结局
Resolution of infection
时间窗: 96 hours after catheter replacement
Composite endpoint of absolute reduction of C-reactive protein and negativity of blood culture results at 48 and 96 hours (combinated with augmented binary method)
次要结局
- Reduction of IL-6(48 hours and 96 hours after catheter replacement)
- Antibiotic-free days at day 28(28 days)
- Reduction of C-reactive protein(48 hours and 96 hours after catheter replacement)
- Negativity of blood culture results(48 hours and 96 hours after catheter replacement)
- Reduction of white blood cell count(48 hours and 96 hours after catheter replacement)
- Vasopressor-free days at day 28(28 days)
- Reduction of Procalcitonin(48 hours and 96 hours after catheter replacement)
- 28-day survival(28 days)
- ICU-free days at day 28(28 days)
- Invasive mechanical ventilation-free days at day 28(28 days)