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

Completed

• Conditions: Staphylococcus Aureus; Surgical Wound Infection

• Registration Number: NCT02935244
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-17
• Study Start: 2016-12
• Primary Completion: 2019-11
• Study Completion: 2020-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5004

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of S. aureus SSI	Up to 90 days following surgery.

Secondary Outcome Measures

Name	Time	Method
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 post-surgical all-cause mortality	Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection	Up to 90 days following surgery
Characterization of S. aureus isolates involved in colonization	At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)	Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
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)
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
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization	Up to 90 days following surgery
Characterization of S. aureus isolates involved in infections	Up to 90 days following surgery	Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.	No more than 30 days prior to 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)

Trial Locations

Locations (33)

Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent; 🇧🇪 Gent, Belgium

H. Hartziekenhuis; 🇧🇪 Lier, Belgium

St. Anne's University Hospital Brno; 🇨🇿 Brno Střed, Czechia

University Hospital Hradec Kralove; 🇨🇿 Nový Hradec Králové, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia

University Hospital Motol; 🇨🇿 Praha, Czechia

North Estonia Medical Centre; 🇪🇪 Tallin, Estonia

Tartu University Clinic; 🇪🇪 Tartu, Estonia

Centre Hospitalier Universitaire de Limoges; 🇫🇷 Limoges, France

Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona; 🇮🇹 Ancona, Italy

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