跳至主要内容
临床试验/NCT06089044
NCT06089044已完成不适用

Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

Tourcoing Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
efficacy of suppressive Dalbavancin therapy

研究概览

简要总结

The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:

What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.

Translated with www.DeepL.com/Translator (free version)

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

  • Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
  • Patients requiring suppressive antibiotic therapy (>6 months) with dalbavancin.

排除标准

  • Patients who are protected adult;
  • Patients who are minors;
  • Patients having expressed their opposition

结局指标

主要结局

efficacy of suppressive Dalbavancin therapy

时间窗: two-year follow-up after initiation of suppressive therapy with Dalbavancin

Proportion of patients successfully treated with Dalbavancin. The efficacy of suppressive therapy will be defined over a two-year period after initiation of treatment as the combination of the following criteria: Clinical control of infection : * Absence of local inflammatory signs (erythema, discharge, edema, pain) ; * Absence of general signs (hyperthermia: T°\>38 or hypothermia T°\< 36°); Biological control: o CRP negative (\<5mg/l) ;

次要结局

未报告次要终点

研究者

发起方
Tourcoing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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