2023-504986-22-00招募中3 期
Linezolid or vancomycin surgical site infection prophylaxis LOVip
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,160
- 试验地点
- 17
- 主要终点
- The primary objective of this study is to show the non-inferiority in terms of rate of d30 post-surgery SSIs in patients receiving linezolid 1200 mg as surgical antibiotic prophylaxis compared with patients receiving vancomycin 30 mg/kg.
研究概览
简要总结
To demonstrate the non-inferiority of linezolid versus vancomycin as surgical antibiotic prophylaxis for all types of surgery in term of SSIs prevention at day-30 after surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years) patients undergoing any elective surgery for which vancomycin is recommended in the guidelines as an alternative to beta-lactams, from different specialties including: neurological, cardiac, orthopedic, vascular, urology, ENT, maxillo-facial or digestive . It is possible to include patients undergoing a re-intervention, if it is not due to a suspected or proven infection.
- •Known allergy to beta-lactams AND/OR suspected or proven MRSA colonization. Proven MRSA colonization is defined as a positive patient sample within 3 months prior to surgery. Suspected MRSA colonization is defined when the patient has received antibiotic treatment within 3 months prior to surgery or is undergoing re-intervention more than 5 days after the first surgery.
- •Signed informed consent
- •Patient affiliated to a social security system or equivalent.
排除标准
- •Surgery for suspected or proven SSI according to international definitions
- •Obesity defined by a body mass index (BMI) >35 kg/m2 or a body weight >100 kg
- •Chronic kidney disease defined as glomerular filtration rate (GFR) <60 ml/min per 1.73 m2
- •Known allergy to linezolid or vancomycin or one of the excipients in their respective composition
- •Patient with a history of hematologic malignancy or with ongoing hematologic malignancy
- •Declared pregnancy or breastfeeding
- •Patient under legal protection regime for adults
- •Patient already enrolled in LOVip study for a previous surgery
- •Patient with limited French proficiency
结局指标
主要结局
The primary objective of this study is to show the non-inferiority in terms of rate of d30 post-surgery SSIs in patients receiving linezolid 1200 mg as surgical antibiotic prophylaxis compared with patients receiving vancomycin 30 mg/kg.
The primary objective of this study is to show the non-inferiority in terms of rate of d30 post-surgery SSIs in patients receiving linezolid 1200 mg as surgical antibiotic prophylaxis compared with patients receiving vancomycin 30 mg/kg.
次要结局
未报告次要终点
研究者
coordinating investigator
Scientific
Assistance Publique Hopitaux De Marseille
研究点 (17)
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