Clinical trial NCT02935244: Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
Official title: Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Surgical Wound Infection
Keywords: Epidemiology
Staphylococcus aureus
Prospective observational
Surgical site or wound infection
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: MedImmune LLC
First posted: 2016-10-17
Enrollment: 5004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of S. aureus SSI
timeFrame: Up to 90 days following surgery.
Secondary outcomes:
measure: Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus bloodstream infection
timeFrame: Up to 90 days following surgery
measure: Incidence of other post-surgical S. aureus infection
timeFrame: Up to 90 days following surgery
measure: Incidence of all-cause SSI, by etiologic agent
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI stratified by antibiotic susceptibility
timeFrame: Up to 90 days following surgery
measure: Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
timeFrame: No more than 30 days prior to surgery
measure: Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
timeFrame: Up to 90 days following surgery
measure: Incidence of post-surgical all-cause mortality
timeFrame: Up to 90 days following surgery
measure: Semi-quantification of the bacterial load of colonizing S. aureus
timeFrame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
measure: Characterization of S. aureus isolates involved in colonization
timeFrame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
measure: Serum antibody levels against S. aureus virulence factors.
timeFrame: Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample)
measure: Characterization of S. aureus isolates involved in infections
timeFrame: Up to 90 days following surgery
Other outcomes:
measure: 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
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI, stratified by participating country
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI, stratified by type of surgery
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI, stratified by wound classification
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI, stratified by urgency of surgery
timeFrame: Up to 90 days following surgery
measure: Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification
timeFrame: Up to 90 days following surgery
Locations:
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
city: Lier
country: Belgium
facility: H. Hartziekenhuis
city: Brno Střed
country: Czechia
facility: St. Anne's University Hospital Brno
city: Nový Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Praha
country: Czechia
facility: University Hospital Motol
city: Tallin
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Tartu University Clinic
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
city: Brescia
country: Italy
facility: BRESCIA Hospital
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
city: Assen
country: Netherlands
facility: Wilhemina Ziekenhuis Assen
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Bukarest
country: Romania
facility: Carol Davila University of Medicine and Pharmacy Bucharest
city: Bukarest
country: Romania
facility: Elias university emergency hospital
city: Bukarest
country: Romania
facility: Prof. C.C. Iliescu Cardiovascular Diseases Institute
city: Timişoara
country: Romania
facility: Clinic County Hospital Timisoara
city: Belgrad
country: Serbia
facility: Clinical Centre of Serbia
city: Belgrad
country: Serbia
facility: Institute for Orthopedic Surgery Banjica
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cadiz
country: Spain
facility: Hospital Universitari del Mar
city: Córdoba
country: Spain
facility: HU Reina Sophia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospital NHS Trust
city: Derby
country: United Kingdom
facility: Derby Teaching Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust Manchester
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: York
country: United Kingdom
facility: York Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: UMC Utrecht
name: Jan AJW Kluytmans, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: