Designing the ASPIRE-SSI study: a multicenter, observational, prospective cohort study to assess the incidence and risk factors of surgical site and bloodstream infections caused by Staphylococcus aureus in Europe

Background There is a continuing need for in-depth and updated knowledge about the epidemiology of surgical site infections (SSIs) caused by Staphylococcus aureus to support the development of effective preventive interventions. The ASPIRE-SSI study aims primarily to determine the incidence of S. aureus SSIs and postoperative bloodstream infections (BSIs) in Europe and to assess their association with patient-related, pathogen-related, and contextual risk factors. Methods ASPIRE-SSI is a prospective, multicenter, observational cohort study primarily assessing the incidence of and risk factors for S. aureus SSI and postoperative BSI in Europe. Five thousand adult surgical patients (of which two-thirds will be S. aureus carriers and one-third non-carriers) undergoing several types of surgical procedures in sites located across Europe were enrolled in the study. Data and specimens were collected from these subjects who were followed for up to 90 days following surgery to assess study outcomes. Using advanced survival analyses and regression techniques (including competing risks models), we will determine event-specific and sub-distribution hazards to assess the independent associations of these study outcomes with risk factors. Additionally, a risk prediction model will be derived to quantify the risk of developing SSI or BSI due to S. aureus . Discussion Despite the challenges, this study will provide important and contemporary information about the epidemiology of SSI and BSI (and other infections) caused by S. aureus in the current surgical population in Europe, thereby supporting the development of effective preventive interventions. Trial registration [clinicaltrial.gov][1] number NCT02935244 ### Competing Interest Statement All authors have completed the ICMJE uniform disclosure form at [www.icmje.org/coi_disclosure.pdf][2] and declare:no support from any organization for the submitted work; O.A. and F.S were employed and paid a salary by AstraZeneca during the preparation and conduct of this study, F.S. is currently employed by Boehringer Ingelheim Pharmaceuticals, Inc., S.H. has received fees for participation in a scientific advisory board of Sandoz; no other relationships or activities that could appear to have influenced the submitted work. ### Clinical Trial NCT02935244 ### Clinical Protocols ### Funding Statement This research project received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement number 115523 resources of which were composed of financial contribution from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Medical Ethics committee Utrecht; Postbus 85500; Huispostnr D01.343; 3508 GA Utrecht; Telephone number: 088 755 6376; e-mail address: metc{at}umcutrecht.nl All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The datasets generated and analyzed during the study are not publicly available due to confidentiality reasons but are available from the corresponding author upon scientific review and approval of the request by the Scientific Committee of the study. A summary of the results will be published on clinicaltrials.gov and in peer-reviewed journals. * ASA : American Society of Anesthesiologists ASPIRE-SSI : Advanced Understanding of Staphylococcus aureus Infections in Europe - Surgical Site Infections BSI : bloodstream infection CDC : Centers for Disease Control and Prevention COMBACTE : Combatting bacterial resistance in Europe HAI : healthcare-associated infection S. aureus : Staphylococcus aureus SSI : surgical site infection SDV : Source data verification. [1]: http://clinicaltrial.gov [2]: http://www.icmje.org/coi_disclosure.pdf