Staphylococcus AureusASPIRE-SSINCT02935244
Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
An observational study of Staphylococcus Aureus and Surgical Wound Infection, run by UMC Utrecht at 33 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Surgical Wound Infection
- How many people
- 5,004 participants
- Where
- 33 sitesin 10 countries
- Study dates
- Dec 2016to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
United Kingdom6 sites
Queen Elizabeth Hospital
Birmingham
Brighton & Sussex University Hospital NHS Trust
Brighton
Derby Teaching Hospitals NHS Foundation Trust
Derby
The Pennine Acute Hospitals NHS Trust Manchester
Manchester
South Tees Hospitals NHS Foundation Trust
Middlesbrough
York Teaching Hospitals NHS Foundation Trust
York
Spain5 sites
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitari del Mar
Cadiz
HU Reina Sophia
Córdoba
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario Virgen Macarena
Seville
Czechia4 sites
St. Anne's University Hospital Brno
Brno-střed
University Hospital Hradec Kralove
Nový Hradec Králové
University Hospital Ostrava
Ostrava
University Hospital Motol
Prague
Romania4 sites
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest
Elias university emergency hospital
Bucharest
Prof. C.C. Iliescu Cardiovascular Diseases Institute
Bucharest
Clinic County Hospital Timisoara
Timișoara
Italy3 sites
Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
Ancona
BRESCIA Hospital
Brescia
Ospedale Infermi di Rimini
Rimini
Netherlands3 sites
Wilhemina Ziekenhuis Assen
Assen
Amphia Hospital
Breda
UMC Utrecht
Utrecht
Serbia3 sites
Clinical Centre of Serbia
Belgrade
Institute for Orthopedic Surgery Banjica
Belgrade
Clinical Centre of Kragujevac
Kragujevac
Belgium2 sites
Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
Ghent
H. Hartziekenhuis
Lier
Estonia2 sites
North Estonia Medical Centre
Tallinn
Tartu University Clinic
Tartu
About this study
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.
Read the 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.
- Conditions
- Staphylococcus Aureus, Surgical Wound Infection
- Keywords
- Epidemiology, Staphylococcus aureus, Prospective observational, Surgical site or wound infection
- Medical subject headings
- Staphylococcal Infections, Surgical Wound Infection, Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of S. aureus SSI
Measured: Up to 90 days following surgery.
Secondary outcomes (12)
Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
Measured: Up to 90 days following surgery
Incidence of S. aureus bloodstream infection
Measured: Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection
Measured: Up to 90 days following surgery
Incidence of all-cause SSI, by etiologic agent
Measured: Up to 90 days following surgery
Incidence of S. aureus SSI stratified by antibiotic susceptibility
Measured: Up to 90 days following surgery
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
Measured: No more than 30 days prior to surgery
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
Measured: Up to 90 days following surgery
Incidence of post-surgical all-cause mortality
Measured: Up to 90 days following surgery
Semi-quantification of the bacterial load of colonizing S. aureus
Measured: 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
Measured: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Serum antibody levels against S. aureus virulence factors.
Measured: 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
Measured: Up to 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Principal investigator, Jan Kluytmans, UMC Utrecht
- Investigators
- Jan AJW Kluytmans, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935244
- Sponsor's protocol ID
- NL57595.041.16
- Acronym
- ASPIRE-SSI
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2016
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
- ClinicalTrials.gov ID
- NCT02935244
- Acronym / sponsor ID
- ASPIRE-SSI / NL57595.041.16
- Conditions
- Staphylococcus Aureus, Surgical Wound Infection
- Keywords
- Epidemiology, Staphylococcus aureus, Prospective observational, Surgical site or wound infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,004 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of S. aureus SSI
Time frame: Up to 90 days following surgery.
12 secondary outcomes
Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
Time frame: Up to 90 days following surgery
Incidence of S. aureus bloodstream infection
Time frame: Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection
Time frame: Up to 90 days following surgery
Incidence of all-cause SSI, by etiologic agent
Time frame: Up to 90 days following surgery
Incidence of S. aureus SSI stratified by antibiotic susceptibility
Time frame: Up to 90 days following surgery
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
Time frame: No more than 30 days prior to surgery
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
Time frame: Up to 90 days following surgery
Incidence of post-surgical all-cause mortality
Time frame: Up to 90 days following surgery
Semi-quantification of the bacterial load of colonizing S. aureus
Time frame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Characterization of S. aureus isolates involved in colonization
Time frame: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Serum antibody levels against S. aureus virulence factors.
Time frame: 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
Time frame: Up to 90 days following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan AJW Kluytmans, MD PhD principal investigator
UMC Utrecht
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus and Surgical Wound Infection, run by UMC Utrecht at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom, Spain, Czechia, Romania, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of S. aureus SSI (time frame: Up to 90 days following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.