Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
- Conditions
- Staphylococcus AureusSurgical Wound Infection
- Registration Number
- NCT02935244
- Lead Sponsor
- UMC Utrecht
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5004
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of S. aureus SSI Up to 90 days following surgery.
- Secondary Outcome Measures
Name Time Method Incidence of post-surgical all-cause mortality Up to 90 days following surgery 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 Characterization of S. aureus isolates involved in colonization 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
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 Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
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)
Trial Locations
- Locations (33)
Amphia Hospital
🇳🇱Breda, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Elias university emergency hospital
🇷🇴Bukarest, Romania
Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
🇧🇪Gent, 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
🇨🇿Praha, Czechia
North Estonia Medical Centre
🇪🇪Tallin, Estonia
Ospedale Infermi di Rimini
🇮🇹Rimini, Italy
Clinical Centre of Serbia
🇷🇸Belgrad, Serbia
Tartu University Clinic
🇪🇪Tartu, Estonia
Centre Hospitalier Universitaire de Limoges
🇫🇷Limoges, France
Wilhemina Ziekenhuis Assen
🇳🇱Assen, Netherlands
Carol Davila University of Medicine and Pharmacy Bucharest
🇷🇴Bukarest, Romania
Prof. C.C. Iliescu Cardiovascular Diseases Institute
🇷🇴Bukarest, Romania
Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
🇮🇹Ancona, Italy
BRESCIA Hospital
🇮🇹Brescia, Italy
Clinic County Hospital Timisoara
🇷🇴Timişoara, Romania
Institute for Orthopedic Surgery Banjica
🇷🇸Belgrad, Serbia
Clinical Centre of Kragujevac
🇷🇸Kragujevac, Serbia
HU Reina Sophia
🇪🇸Córdoba, Spain
Hospital Universitari del Mar
🇪🇸Cadiz, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Brighton & Sussex University Hospital NHS Trust
🇬🇧Brighton, United Kingdom
South Tees Hospitals NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Derby Teaching Hospitals NHS Foundation Trust
🇬🇧Derby, United Kingdom
The Pennine Acute Hospitals NHS Trust Manchester
🇬🇧Manchester, United Kingdom
York Teaching Hospitals NHS Foundation Trust
🇬🇧York, United Kingdom