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临床试验/NCT04123964
NCT04123964Unknown不适用

Use of Probabilist Broad-spectrum β-lactam for One-stage Replacement of Infected Hip / Knee Arthroplasties: Retrospective Analysis in a Center of Reference

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Retrospective study of the use of β-lactams in infected of hip or knee prosthesis

研究概览

简要总结

According to the official recommendations, infected prosthesis can be surgically treated by one or two-stage replacement. In Strasbourg, the investigators only perform one-stage surgery, which means that the new materiel is put directly into an infected site. To prevent re-infection, probabilist antibiotherapy has to be started the earlier as possible and to have the larger specter as possible. Official recommendations don't specify the best choice of antibiotherapy and let prescriptors make choice, according to the local epidemiology and patient's history.

In Strasbourg, the investigators systematically start an antibiotic against cocci gram positive: daptomycin. Sometimes, the investigators add tazocillin, a broad-spectrum β-lactam against bacillus gram negative. To determine if the investigators use the second one, they focalized on the presence of fistula or not. Indeed, enterobacteriae from gastro-intestinal tractus are also found on the skin and can move to the peri-prosthetic site if a fistula is created. The major disadvantage of this board-spectrum antibiotic is the selection and creation of resistant bacteriae, which can be responsible of failure, re-infection, or just spreading on the environnement.

The primary purpose is to evaluate retrospectively the prescription of tazocillin, judging it's necessity thanks to antibiograms performed on samples taken during surgery. The aim is to evaluate if the criteria " fistula or not " is a good one to guide the prescription of board-spectrum β-lactam.

Secondary purposes are to find the etiology of failures ( bacteriological failure or re-infection with a new pathogen), evaluate the apparition of multi-drug resistant bacteriae and infections they are responsible for, looking for others criterias which could help the investigators to choose the probablist antibiotherapy

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

  • Adults ( > 18 years-old) hospitalized from 1st January 2018 to 31th December 2018 in the septic orthopedic surgery unity of the university hospital of Strasbourg for a prosthetic-joint infection (knee or hip) treated by replacement.
  • Patients who mentioned they agree for scientific use of their medical data.

排除标准

  • Patients hospitalized only for the second surgery of a two-stage replacement.
  • Patients who refused or didn't agree with scientific use of their medical data.
  • Adults with legal protective measures.

结局指标

主要结局

Retrospective study of the use of β-lactams in infected of hip or knee prosthesis

时间窗: Files analysed retrospectily from January 1st, 2018 to December 31st, 2018 will be examined

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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