Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

Conditions
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Staphylococcus Aureus, Surgical Wound Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of S. aureus SSI |  | Up to 90 days following surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 other post-surgical S. aureus infection |  | Up to 90 days following surgery | 
| 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 | 
| Prevalence of preoperative S. aureus colonization in nose, throat and perineal region. |  | No more than 30 days prior to surgery | 
| Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization |  | Up to 90 days following surgery | 
| Incidence of post-surgical all-cause mortality |  | Up to 90 days following 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) | 
| Characterization of S. aureus isolates involved in colonization | 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. |  | 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 | Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates | Up to 90 days following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidemiology, Staphylococcus aureus, Prospective observational, Surgical site or wound infection