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Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections (ASPIRE-SSI)

2021年4月28日 更新者：Jan Kluytmans、UMC Utrecht
ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

研究概览

地位

完全的

条件

详细说明

The primary objective of ASPIRE-SSI is to determine the incidence of S. aureus infections, particularly S. aureus SSIs, in various adult surgical patient populations, and to identify the patient-related, pathogen-related, and contextual risk factors for the development of S. aureus SSI. Using this information, a SSI prediction tool will be derived for future clinical trials and public health interventions aimed at SSI prevention. Furthermore, immunologic features protective against S. aureus SSI will also be assessed.

The knowledge obtained by this study will enable identification of the surgical patients most at risk of developing S. aureus infections, particularly S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.

研究类型

观察性的

注册 (实际的)

5004

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 塞尔维亚
      • Belgrad、塞尔维亚
        • Clinical Centre of Serbia
      • Belgrad、塞尔维亚
        • Institute for Orthopedic Surgery Banjica
      • Kragujevac、塞尔维亚
        • Clinical Centre of Kragujevac
  • 意大利
      • Ancona、意大利
        • Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
      • Brescia、意大利
        • Brescia Hospital
      • Rimini、意大利
        • Ospedale infermi di Rimini
  • 捷克语
      • Brno Střed、捷克语
        • St. Anne's University Hospital Brno
      • Nový Hradec Králové、捷克语
        • University Hospital Hradec Kralove
      • Ostrava、捷克语
        • University Hospital Ostrava
      • Praha、捷克语
        • University Hospital Motol
  • 比利时
      • Gent、比利时
        • Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
      • Lier、比利时
        • H. Hartziekenhuis
  • 法国
      • Limoges、法国
        • Centre Hospitalier Universitaire de Limoges
  • 爱沙尼亚
      • Tallin、爱沙尼亚
        • North Estonia Medical Centre
      • Tartu、爱沙尼亚
        • Tartu University Clinic
  • 罗马尼亚
      • Bukarest、罗马尼亚
        • Carol Davila University of Medicine and Pharmacy Bucharest
      • Bukarest、罗马尼亚
        • Elias University Emergency Hospital
      • Bukarest、罗马尼亚
        • Prof. C.C. Iliescu Cardiovascular Diseases Institute
      • Timişoara、罗马尼亚
        • Clinic County Hospital Timisoara
  • 英国
      • Birmingham、英国
        • Queen Elizabeth Hospital
      • Brighton、英国
        • Brighton & Sussex University Hospital NHS Trust
      • Derby、英国
        • Derby Teaching Hospitals NHS Foundation Trust
      • Manchester、英国
        • The Pennine Acute Hospitals NHS Trust Manchester
      • Middlesbrough、英国
        • South Tees Hospitals NHS Foundation Trust
      • York、英国
        • York Teaching Hospitals NHS Foundation Trust
  • 荷兰
      • Assen、荷兰
        • Wilhemina Ziekenhuis Assen
      • Breda、荷兰
        • Amphia Hospital
      • Utrecht、荷兰
        • UMC Utrecht
  • 西班牙
      • Barcelona、西班牙
        • Hospital Universitari de Bellvitge
      • Cadiz、西班牙
        • Hospital Universitari del Mar
      • Córdoba、西班牙
        • HU Reina Sophia
      • Oviedo、西班牙
        • Hospital Universitario Central de Asturias
      • Sevilla、西班牙
        • Hospital Universitario Virgen Macarena

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients undergoing 1 of the protocol-defined surgical procedures are eligible for inclusion in the study. However, enrolment in the study cohort population will be based on preoperative S. aureus colonization. In total, approximately 3300 S. aureus colonized subjects and 1700 non-colonized subjects will be enrolled in the study cohort population.

Protocol-defined surgical procedures: Coronary artery bypass grafting; ICD implantation; knee and hip prosthesis surgery; laminectomy and spinal fusion surgery; emergency surgery; central artery reconstructive and peripheral artery bypass surgery; mastectomy; and craniotomy.

描述

Inclusion Criteria:

  • The subject is 18 years of age or older.
  • The subject is undergoing 1 of the protocol-defined surgical procedures. The surgical procedure is planned or unplanned.
  • The subject has been screened for S. aureus colonization from three body regions: nose, throat, and perineum within 30 days prior to surgery, and based on the preoperative S. aureus colonization status of the subject, the subject qualifies for enrolment in the study cohort.
  • Written informed consent has been obtained prior to enrollment in the study cohort.

Exclusion criteria:

  • Parallel participation in any experimental study of an anti-Staphylococcus preventive intervention.
  • An active diagnosis of a SSI as the reason for surgery.
  • Not able to comply with study procedures and follow-up based on Investigator judgment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of S. aureus SSI
大体时间：Up to 90 days following surgery.
Up to 90 days following surgery.

次要结果测量

结果测量
措施说明
大体时间
Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus bloodstream infection
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of all-cause SSI, by etiologic agent
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI stratified by antibiotic susceptibility
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
大体时间：No more than 30 days prior to surgery
No more than 30 days prior to surgery
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of post-surgical all-cause mortality
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Semi-quantification of the bacterial load of colonizing S. aureus
大体时间：At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Characterization of S. aureus isolates involved in colonization
大体时间：At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Serum antibody levels against S. aureus virulence factors.
大体时间：Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample)
Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample)
Characterization of S. aureus isolates involved in infections
大体时间：Up to 90 days following surgery
Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
Up to 90 days following surgery

其他结果措施

结果测量
大体时间
Magnitude of healthcare utilization associated with S. aureus SSI in terms of: a. Duration of length of stay (LOS) b. Incidence of readmissions, including re-interventions due to S. aureus SSI c. Duration of LOS during readmissions
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by participating country
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by type of surgery
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by wound classification
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by urgency of surgery
大体时间：Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification
大体时间：Up to 90 days following surgery
Up to 90 days following surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UMC Utrecht

合作者

MedImmune LLC

调查人员

  • 首席研究员：Jan AJW Kluytmans, MD PhD、UMC Utrecht

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月1日

初级完成 (实际的)

2019年11月1日

研究完成 (实际的)

2020年1月1日

研究注册日期

首次提交

2016年7月20日

首先提交符合 QC 标准的

2016年10月12日

首次发布 (估计)

2016年10月17日

研究记录更新

最后更新发布 (实际的)

2021年5月3日

上次提交的符合 QC 标准的更新

2021年4月28日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NL57595.041.16

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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