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临床试验/NCT07303101
NCT07303101招募中不适用

One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年5月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
16
试验地点
1
主要终点
Candida spp. infection eradication rate

研究概览

简要总结

Accounting for only 0.7% to 3% of joint prosthesis infections, yeast infections are considered particularly difficult to treat. They are primarily caused by Candida yeasts, representing over 90% of cases.

Surgical treatment is the cornerstone of managing periprosthetic infections. In cases of chronic bacterial infections, complete implant replacement is necessary and can be performed either in one or two stages.

However, for chronic Candida spp. infections, two-stage prosthesis replacement remains the preferred option. Only three retrospective, single-center studies have evaluated the success rate of one-stage prosthesis replacement in periprosthetic Candida spp. infections in selected patients. Although the sample sizes of these studies are small, the 2-year success rate of 63% to 81% differs little from that of two-stage implant replacement (47% to 100%). Furthermore, systemic antifungal treatment is poorly defined. Recommendations are based on studies with a low level of evidence. The hypothesis is that a single-stage prosthesis replacement combined with appropriate antifungal treatment for chronic periprosthetic Candida spp. infection has the same outcome as a two-stage prosthesis replacement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patient aged over 18 years at the time of prosthesis revision
  • Operated on at the Strasbourg University Hospitals (HUS) between January 1, 2013, and December 31, 2021
  • Hip or knee prosthesis revision
  • Possible or proven periprosthetic Candida spp. infection according to the EBJIS diagnostic criteria
  • Minimum of 3 deep samples (joint fluid, preoperative sample, and/or prosthesis sonication)

排除标准

  • Patient undergoing lavage, synovectomy, and implant preservation
  • Patient not receiving systemic antifungal treatment after prosthesis replacement
  • Patient with another proven Candida spp. infection or infective endocarditis
  • Patient for whom suppressive therapy was prescribed prior to surgery.

结局指标

主要结局

Candida spp. infection eradication rate

时间窗: for the duration of hospital stay, up to 1 year

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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