Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

NCT02935244 | Completed

• 1 other identifier: NL57595.041.16
• Study Type: observational
• Target: 5,004
• Locations: 9 countries
• Sites: 28

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.

Conditions

Staphylococcus Aureus; Surgical Wound Infection

Keywords

Epidemiology; Staphylococcus aureus; Prospective observational; Surgical site or wound infection

Outcome Measures

Primary Outcomes (1)

• Incidence of S. aureus SSI

  Up to 90 days following surgery.

Secondary Outcomes (12)

• 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

Other Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• MedImmune LLC: collaborator

Study Sites (33)

Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent

Ghent, Belgium

Location

H. Hartziekenhuis

Lier, Belgium

Location

St. Anne's University Hospital Brno

Brno-střed, Czechia

Location

University Hospital Hradec Kralove

Nový Hradec Králové, Czechia

Location

University Hospital Ostrava

Ostrava, Czechia

Location

University Hospital Motol

Prague, Czechia

Location

North Estonia Medical Centre

Tallinn, Estonia

Location

Tartu University Clinic

Tartu, Estonia

Location

Centre Hospitalier Universitaire de Limoges

Limoges, France

Location

Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona

Ancona, Italy

Location

BRESCIA Hospital

Brescia, Italy

Location

Ospedale Infermi di Rimini

Rimini, Italy

Location

Wilhemina Ziekenhuis Assen

Assen, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Carol Davila University of Medicine and Pharmacy Bucharest

Bucharest, Romania

Location

Elias university emergency hospital

Bucharest, Romania

Location

Prof. C.C. Iliescu Cardiovascular Diseases Institute

Bucharest, Romania

Location

Clinic County Hospital Timisoara

Timișoara, Romania

Location

Clinical Centre of Serbia

Belgrade, Serbia

Location

Institute for Orthopedic Surgery Banjica

Belgrade, Serbia

Location

Clinical Centre of Kragujevac

Kragujevac, Serbia

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitari del Mar

Cadiz, Spain

Location

HU Reina Sophia

Córdoba, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Brighton & Sussex University Hospital NHS Trust

Brighton, United Kingdom

Location

Derby Teaching Hospitals NHS Foundation Trust

Derby, United Kingdom

Location

The Pennine Acute Hospitals NHS Trust Manchester

Manchester, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

Location

York Teaching Hospitals NHS Foundation Trust

York, United Kingdom

Location

Related Links

• Design paper

Biospecimen

Retention: SAMPLES WITH DNA

* A preoperative blood sample * An additional blood sample after an SSI episode

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan AJW Kluytmans, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: October 17, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

GB (6); BE (2); ES (2); NL (3); IT (3); SE (3); RO (4); CZ (4); FR (1)