ASPIRE-SSI
Research type
Research Study
Full title
Advanced understanding of StaPhylococcus aureus Infections in EuRopE – Surgical Site Infections (ASPIRE-SSI)
IRAS ID
224249
Contact name
Miruna David
Contact email
Sponsor organisation
UMC Utrecht, div. Julius Centrum
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Surgical site infections (SSIs) occur frequently and cause considerable morbidity, mortality and costs. An important causative pathogen of a SSI is Staphylococcus aureus. The epidemiology of S. aureus SSI has not been fully described, but is urgently needed for the development of preventive interventions against S. aureus SSIs.
Primary objective:
· To assess the incidence of S. aureus SSI up to 90 days following surgery and its association with patient-related, pathogen-related and contextual factors.Main secondary objectives:
· To develop a robust S. aureus SSI and bloodstream infection (BSI) prediction tool for future clinical trials and interventions.
· To assess the incidence of serious S. aureus SSI up to 90 days following surgery and its independent association with patient-related, pathogen-related and contextual factors.
· To assess the incidence of S. aureus BSI up to 90 days following surgery and its independent association with patient-related, pathogen-related and contextual factors.
· To assess the incidence of all-cause SSI up to 90 days following surgery.
· To assess the incidence of S. aureus SSI stratified by antibiotic susceptibility up to 90 days following surgery.
· To compare the prevalence of preoperative S. aureus colonisation in the nose, throat and perineum.
· To characterise S. aureus isolates involved in colonisation and infection and explore the role of anti-Staphylococcal antibodies as potential biomarkers for S. aureus SSI and/or serious S. aureus infection.Study design: A prospective, observational, multicentre cohort study that will be conducted in sites distributed across the 4 European sub-regions.
Study participants: Patients (18 years of age or older) undergoing 1 or more of the protocol-listed surgical procedures are eligible for inclusion in the study. However, enrolment in the study cohort population will be based on preoperative S. aureus colonisation. In total, approximately 3300 S. aureus colonised subjects and 1700 non-colonised subjects will be enrolled in the study cohort population. These subjects will be followed for up to 90 days from the day of surgery to assess study outcomes.
REC name
Wales REC 1
REC reference
17/WA/0162
Date of REC Opinion
9 Jun 2017
REC opinion
Unfavourable Opinion