The aim of this study is to identify patient related, pathogen related, and contextual factors involved in S. aureus infections, especially S. aureus SSI, in the current surgical patient population in Europe, to identify patient groups with an…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the incidence of S. aureus SSI up to 90 days following surgery and
its independent association with patient-related, pathogen-related and
contextual factors.
Secondary outcome
*To develop a robust S. aureus SSI and bloodstream infection (BSI) prediction
tool for future clinical trials and public health interventions.
*To assess the incidence of serious S. aureus SSI up to 90 days following
surgery and its independent association with patient-related, pathogen-related
and contextual factors.
*To assess the incidence of S. aureus BSI up to 90 days following surgery and
its independent association with patient-related, pathogen-related and
contextual factors.
*To assess the incidence of all-cause SSI up to 90 days following surgery.
*To assess the incidence of S. aureus SSI stratified by antibiotic
susceptibility up to 90 days following surgery.
*To compare the prevalence of preoperative S. aureus colonization in the nose,
throat and perineal region.
*To characterize S. aureus isolates involved in colonization and infection and
explore the role of anti-Staphylococcal antibodies as potential biomarkers for
S. aureus SSI and/or serious S. aureus infection.
Background summary
Surgical site infections (SSIs) are healthcare-associated infections that occur
frequently and cause considerable morbidity, mortality and healthcare costs. An
important causative pathogen of a SSI is Staphylococcus aureus. The
epidemiology of S. aureus SSI has not been fully described, but is urgently
needed to support the development of preventive interventions against S. aureus
SSIs.
Study objective
The aim of this study is to identify patient related, pathogen related, and
contextual factors involved in S. aureus infections, especially S. aureus SSI,
in the current surgical patient population in Europe, to identify patient
groups with an increased risk on developing these infections, and the
prevalence of preoperative S. aureus colonization in nose, throat, and perineal
region.
Study design
A prospective, observational, multicenter cohort study that will be conducted
in sites distributed across the 4 European sub-regions.
Study burden and risks
Risks associated with participation are minimal since the study procedures
necessary for participation are considered relatively safe (e.g. nose swab or
venous puncture). The burden of participation in this study is thus considered
to be minimal for the same reasons.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. The subject is 18 years of age or older.
2. The subject is undergoing 1 or more of the 10 surgical procedures listed in this protocol. The surgical procedure is planned or unplanned.
3. 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.
4. Written informed consent has been obtained from the subject prior to enrollment in the study cohort.
Exclusion criteria
1. Parallel participation in any experimental study of an anti-Staphylococcus preventive intervention.
2. An active diagnosis of a SSI as the reason for surgery.
3. Not able to comply with study procedures and follow-up based on Investigator judgment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02935244 |
| CCMO | NL57595.041.16 |