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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Surgical Wound 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.

• Study Type: Observational
• Enrollment (Actual): 5004

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
  • Lier, Belgium
    • H. Hartziekenhuis
• Czechia
  • Brno Střed, Czechia
    • St. Anne's University Hospital Brno
  • Nový Hradec Králové, Czechia
    • University hospital Hradec Králové
  • Ostrava, Czechia
    • University Hospital Ostrava
  • Praha, Czechia
    • University Hospital Motol
• Estonia
  • Tallin, Estonia
    • North Estonia Medical Centre
  • Tartu, Estonia
    • Tartu University Clinic
• France
  • Limoges, France
    • Centre Hospitalier Universitaire de Limoges
• Italy
  • Ancona, Italy
    • Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
  • Brescia, Italy
    • Brescia Hospital
  • Rimini, Italy
    • Ospedale Infermi di Rimini
• Netherlands
  • Assen, Netherlands
    • Wilhemina Ziekenhuis Assen
  • Breda, Netherlands
    • Amphia Hospital
  • Utrecht, Netherlands
    • UMC Utrecht
• Romania
  • Bukarest, Romania
    • Carol Davila University of Medicine and Pharmacy Bucharest
  • Bukarest, Romania
    • Elias University Emergency Hospital
  • Bukarest, Romania
    • Prof. C.C. Iliescu Cardiovascular Diseases Institute
  • Timişoara, Romania
    • Clinic County Hospital Timisoara
• Serbia
  • Belgrad, Serbia
    • Clinical Centre of Serbia
  • Belgrad, Serbia
    • Institute for Orthopedic Surgery Banjica
  • Kragujevac, Serbia
    • Clinical Centre of Kragujevac
• Spain
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Cadiz, Spain
    • Hospital Universitari del Mar
  • Córdoba, Spain
    • HU Reina Sophia
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital
  • Brighton, United Kingdom
    • Brighton & Sussex University Hospital NHS Trust
  • Derby, United Kingdom
    • Derby Teaching Hospitals NHS Foundation Trust
  • Manchester, United Kingdom
    • The Pennine Acute Hospitals NHS Trust Manchester
  • Middlesbrough, United Kingdom
    • South Tees Hospitals NHS Foundation Trust
  • York, United Kingdom
    • York Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing 1 of the protocol-defined surgical procedures are eligible for inclusion in the study. However, enrolment in the study cohort population will be based on preoperative S. aureus colonization. In total, approximately 3300 S. aureus colonized subjects and 1700 non-colonized subjects will be enrolled in the study cohort population.

Protocol-defined surgical procedures: Coronary artery bypass grafting; ICD implantation; knee and hip prosthesis surgery; laminectomy and spinal fusion surgery; emergency surgery; central artery reconstructive and peripheral artery bypass surgery; mastectomy; and craniotomy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Magnitude of healthcare utilization associated with S. aureus SSI in terms of: a. Duration of length of stay (LOS) b. Incidence of readmissions, including re-interventions due to S. aureus SSI c. Duration of LOS during readmissions	Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by participating country	Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by type of surgery	Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by wound classification	Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by urgency of surgery	Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification	Up to 90 days following surgery

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: MedImmune LLC
• Investigators: Principal Investigator: Jan AJW Kluytmans, MD PhD, UMC Utrecht

Publications and helpful links

Helpful Links

• Design paper

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Epidemiology; Staphylococcus aureus; Prospective observational; Surgical site or wound infection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection; Staphylococcal Infections
• Other Study ID Numbers: NL57595.041.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No