First Patients in ASPIRE-SSI

The study team achieved the first subject enrolled at the University Medical Center Utrecht, Netherlands on December 20, 2016 – within 5 months of protocol approval.

The study is off to a great start with (6) subjects screened and (2) subjects enrolled in the study cohort as of January 23, 2017.  At this time there is only one active site, but the team is working diligently and have selected 13 out of 25 investigational sites in the Netherlands, France, Spain, Italy, United Kingdom and Serbia. Our goal is to initiate all sites by September 2017 and complete study enrollment by July 2018.

ASPIRE-SSI is a prospective, observational, multicentre cohort study to assess the incidence of Staphylococcus aureus (S. aureus) infections, particularly S. aureus surgical site infections, and its associated risk factors in the European surgical patient population.

The study will be conducted in approximately 25 sites across 10 countries from all four European sub-regions. A total of 5,000 patients aged 18 years or older and undergoing pre-selected surgical procedures will be enrolled in the study cohort based on their preoperative S. aureus colonization status. These study cohort subjects will be followed for three months after surgery to assess the occurrence of a S. aureus infection. The results of this study will be used to inform the design of a randomized controlled trial (RCT) that is being planned by partners within COMBACTE.  This RCT will assess an anti-staphylococcal monoclonal antibody intervention in specific high-risk surgical patient subgroups.

If you would like to receive more information about the ASPIRE-SSI study, please send an email to the ASPIRE-SSI study team at ASPIRE-SSI@combacte.com.