Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 5,004
- 试验地点
- 33
- 主要终点
- Incidence of S. aureus SSI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Incidence of S. aureus SSI
时间窗: Up to 90 days following surgery.
次要结局
- Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)(Up to 90 days following surgery)
- Incidence of S. aureus bloodstream infection(Up to 90 days following surgery)
- Incidence of post-surgical all-cause mortality(Up to 90 days following surgery)
- Incidence of other post-surgical S. aureus infection(Up to 90 days following surgery)
- Characterization of S. aureus isolates involved in colonization(At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery))
- Serum antibody levels against S. aureus virulence factors.(Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample))
- Incidence of all-cause SSI, by etiologic agent(Up to 90 days following surgery)
- Incidence of S. aureus SSI stratified by antibiotic susceptibility(Up to 90 days following surgery)
- Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization(Up to 90 days following surgery)
- Characterization of S. aureus isolates involved in infections(Up to 90 days following surgery)
- Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.(No more than 30 days prior to surgery)
- Semi-quantification of the bacterial load of colonizing S. aureus(At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery))