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

Surgical Wound Infection Clinical Trial

— ASPIRE-SSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935244
• Other study ID #: NL57595.041.16
• Status: Completed
• Start date: December 2016
• Est. completion date: January 2020

Study information

• Verified date: April 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5004
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infections
• Staphylococcus Aureus
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	MedImmune LLC

Countries where clinical trial is conducted

Belgium,  Czechia,  Estonia,  France,  Italy,  Netherlands,  Romania,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Incidence of S. aureus SSI, stratified by participating country		Up to 90 days following surgery
Other	Incidence of S. aureus SSI, stratified by type of surgery		Up to 90 days following surgery
Other	Incidence of S. aureus SSI, stratified by wound classification		Up to 90 days following surgery
Other	Incidence of S. aureus SSI, stratified by urgency of surgery		Up to 90 days following surgery
Other	Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification		Up to 90 days following surgery
Primary	Incidence of S. aureus SSI		Up to 90 days following surgery.
Secondary	Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)		Up to 90 days following surgery
Secondary	Incidence of S. aureus bloodstream infection		Up to 90 days following surgery
Secondary	Incidence of other post-surgical S. aureus infection		Up to 90 days following surgery
Secondary	Incidence of all-cause SSI, by etiologic agent		Up to 90 days following surgery
Secondary	Incidence of S. aureus SSI stratified by antibiotic susceptibility		Up to 90 days following surgery
Secondary	Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.		No more than 30 days prior to surgery
Secondary	Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization		Up to 90 days following surgery
Secondary	Incidence of post-surgical all-cause mortality		Up to 90 days following surgery
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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

External Links

•   Design paper