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临床试验/NCT05421312
NCT05421312Unknown4 期

Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip

Radboud University Medical Center0 个研究点目标入组 30 人开始时间: 2022年9月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
30
主要终点
penetration cefazolin into synovial fluid

研究概览

简要总结

To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

详细描述

Periprosthetic joint infection (PJI) is a feared complication of joint replacement, with an incidence of 0.5-1% after primary joint replacement and 3-5% after revision arthroplasty. For orthopaedic surgery involving a prosthesis, the administration of systemic antibiotic prophylaxis is strongly recommended to prevent PJI. Cefazolin is widely used as agent of choice in surgical antibiotic prophylaxis. Previous studies, all performed in patients undergoing primary joint replacement, demonstrated that the concentration of cefazolin in bone and synovial fluid was dose-dependent and exceeds the MIC90 for methicillin susceptible Staphylococcus aureus (MSSA), when given as 1 to 4 gram single dose shortly before incision. When a PJI is already present, clindamycin is used as treatment option in PJI caused by staphylococci (when combined with rifampicin) or cutibacteria. A limited number of studies have been performed to analyse the penetration of clindamycin into bone. These studies showed that clindamycin penetrates well into the bone and concentrations exceeded the MIC90 for MSSA. No studies have been performed to analyse the penetration of antibiotic agents into the periarticular tissue in patients who will undergo revision arthroplasty. In revision arthroplasty a foreign body (prosthesis) is in situ and periarticular tissue condition can be compromised due to previous surgical procedures and the presence of bone reaction to the prosthesis. It is not known whether the difference in PJI incidence after primary and revision arthroplasty may be explained by different penetration of the surgical antibiotic prophylaxis. The aim of this explorative study is to analyse the penetration of cefazolin and clindamycin into synovial fluid and bone and whether the concentration of the agents exceeds the MIC90 for micro-organisms frequently causing PJI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 years or older.
  • Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation (steady state).

排除标准

  • Antibiotic prophylaxis other than cefazolin 2000mg i.v.
  • Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.
  • Clindamycin loaded bone cement in situ.
  • BMI more than 35 kg/m2.

研究组 & 干预措施

Clindamycin

Other

The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.

干预措施: Sampling synovial fluid (Drug)

cefazolin

Other

The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.

干预措施: sampling blood (Drug)

cefazolin

Other

The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.

干预措施: Sampling synovial fluid (Drug)

cefazolin

Other

The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.

干预措施: Sampling bone tissue (Drug)

Clindamycin

Other

The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.

干预措施: sampling blood (Drug)

Clindamycin

Other

The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.

干预措施: Sampling bone tissue (Drug)

结局指标

主要结局

penetration cefazolin into synovial fluid

时间窗: during surgical procedure prior to incision the synovial fluid sample will be taken

The ratio (%) of the concentration of cefazolin in synovial fluid to serum.

penetration cefazolin into bone tissue

时间窗: during surgical procedure prior to incision the synovial fluid sample will be taken

The ratio (%) of the concentration of cefazolin in synovial fluid to serum.

penetration clindamycin into bone tissue

时间窗: during surgical procedure, directly after opening the joint and before reimplantation of the prosthesis the bone samples will be taken

The ratio (%) of the concentration of cefazolin in bone tissue to serum.

次要结局

  • factors associated with reduced clindamycin concentration(sampling during procedure)
  • factors associated with reduced cefazolin concentration(sampling during procedure)
  • AUC/MIC90 of cefazolin(sampling during procedure)
  • AUC/MIC90 of clindamycin(sampling during procedure)

研究者

申办方类型
Other
责任方
Sponsor

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