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临床试验/NCT03191292
NCT03191292已完成不适用

Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
567
试验地点
1
主要终点
collection of probabilistic antibiotic treatment in patients with prosthetic joint infection

研究概览

简要总结

The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
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 with prosthetic joint infection and treated with probabilistic antibiotherapy, between 2010 and 2015, at the Croix-Rousse Hospital

排除标准

  • 未提供

结局指标

主要结局

collection of probabilistic antibiotic treatment in patients with prosthetic joint infection

时间窗: the day of surgery

The type of molecule used and dosage will be described. Probabilistic antibiotic treatment is initiated immediately after the surgery, before the bacteria is identified. The samples are put in bacteriological culture media. The time to obtain results is usually 3 weeks maximum after the surgery because this is the delay for slow-growing bacteria to grow. Then, the empirical treatment can be amended in order to have an antibiotic treatment adapted to the bacteria found.

identification of bacteria involved in patients with prosthetic joint infection

时间窗: 3 weeks after the surgery

The samples collected during the surgery are put in bacteriological culture media. Bacteriological culture of samples collected during surgery for all patients included is made allowing to identify which type of bacteria is involved in the infection, depending on the chronology of the infection (delay between implantation and the presentation of the symptoms \[\< 1 year vs. \> 1 year\])

次要结局

  • Treatment failure(up to 24 months after antibiotic therapy disruption)
  • adverse events(up to 24 months after antibiotic therapy disruption)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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