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临床试验/CTIS2023-504986-22-00
CTIS2023-504986-22-00进行中(未招募)1 期

inezolid or vancomycin surgical site infection prophylaxisLOVip

Assistance Publique Hopitaux De Marseille0 个研究点目标入组 1,160 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
1,160

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

年龄范围
18 至 65+(—)
性别
All

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, •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

研究者

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