Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections (ASPIRE-SSI)

UMC Utrecht

Status: Completed

Conditions: Surgical Wound Infection; Staphylococcus Aureus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02935244

NL57595.041.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.