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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,004
Incidence of S. aureus SSI
Time frame: Up to 90 days following surgery.
Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
Time frame: Up to 90 days following surgery
Incidence of S. aureus bloodstream infection
Time frame: Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection
Time frame: Up to 90 days following surgery
Incidence of all-cause SSI, by etiologic agent
Time frame: Up to 90 days following surgery
Incidence of S. aureus SSI stratified by antibiotic susceptibility
Time frame: Up to 90 days following surgery
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
Time frame: No more than 30 days prior to surgery
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
Time frame: Up to 90 days following surgery
Incidence of post-surgical all-cause mortality
Time frame: Up to 90 days following surgery
Semi-quantification of the bacterial load of colonizing S. aureus
Time frame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
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Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
Ghent, Belgium
H. Hartziekenhuis
Lier, Belgium
St. Anne's University Hospital Brno
Brno-střed, Czechia
University Hospital Hradec Kralove
Nový Hradec Králové, Czechia
University Hospital Ostrava
Ostrava, Czechia
University Hospital Motol
Prague, Czechia
North Estonia Medical Centre
Tallinn, Estonia
Tartu University Clinic
Tartu, Estonia
Centre Hospitalier Universitaire de Limoges
Limoges, France
Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
Ancona, Italy
...and 23 more locations
Characterization of S. aureus isolates involved in colonization
Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
Time frame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Serum antibody levels against S. aureus virulence factors.
Time frame: 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
Time frame: Up to 90 days following surgery