跳至主要内容
临床试验/NCT06189885
NCT06189885尚未招募不适用

Preoperative Daptomycin Prophylaxis for Preventing Gram-Positive or Methicillin-Resistant Staphylococcus Aureus Infection in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
184
试验地点
1
主要终点
Infection

研究概览

简要总结

The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Methicillin-resistant staphylococcus aureus (MRSA) infection is one of the factors leading to the failure of artificial joint infection treatment. Before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. The usual preoperative antibiotic is a first-generation cephalosporin antibiotic. If it is MRSA, vancomycin will be given. Increasingly, literature reports link prosthetic joint infections to MRSA, but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use.

Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. Therefore, it can effectively combat Gram-positive organisms, including MRSA. Daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to Gram-positive organisms. We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. Thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with MRSA coverage (Daptomycin vs. Vancomycin).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 or older with an infection that meets the 2018 International Consensus Meeting (ICM) criteria7 at the time of the first-stage resection arthroplasty with a gram-positive organism, especially MRSA.
  • Will undergo a second stage of reimplantation.

排除标准

  • Patients with a fungal infection or culture-negative infections
  • Known allergies to Cefazolin, Daptomycin, or Vancomycin.
  • Currently receiving surgical treatment for acute postoperative or acute hematogenous PJI.
  • Chronic kidney disease (Creatinine Clearance Rate [CCR] < 30 ml/min/1.73m2)

研究组 & 干预措施

Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Experimental

干预措施: Cefazolin with Daptomycin (Drug)

Preoperative Vancomycin Prophylaxis in Two-Stage Exchange Arthroplasty

Experimental

干预措施: Cefazolin with vancomycin (Drug)

结局指标

主要结局

Infection

时间窗: One year

Infection that meets the 2018 ICM criteria after second stage reimplantation.

次要结局

  • Acute Kidney Injury(48 hours)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Preoperative Daptomycin Prophylaxis in Two-Stage... | 临床试验