ASPIRE-SSI

• Research type

  Research Study

• Full title

  Advanced understanding of StaPhylococcus aureus Infections in EuRopE – Surgical Site Infections (ASPIRE-SSI)

• IRAS ID

  230715

• Contact name

  Miruna David

• Contact email

  miruna.david@uhb.nhs.uk

• Sponsor organisation

  UMC Utrecht, div. Julius Centrum

• Clinicaltrials.gov Identifier

  NCT02935244

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Surgical site infections (SSIs) cause considerable morbidity, mortality and costs. Staphylococcus aureus is a bacterium (a bug) which commonly causes SSI. The patterns, causes and effects of S. aureus SSI have not been fully described, but this kind of information is urgently needed for the development of preventive interventions against S. aureus SSIs.

  Primary objective:
  · To assess the incidence of SSI caused by S. aureus up to 90 days following surgery and determine any risk factors.

  Main secondary objectives:
  · To develop a robust S. aureus SSI and bloodstream infection (BSI) prediction tool for future clinical trials and interventions.
  · To assess the incidence of BSI caused by S. aureus determine any risk factors.
  · To assess the incidence of SSI caused by any type of bacteria.
  · To assess whether any SSI caused by S. aureus are resistant to antibiotics.
  · To compare how often S. aureus is already present in the nose, throat and perineum before surgery.
  · To investigate the traits of S. aureus grown from patients before and after surgery (involved in colonisation and infection) and explore the patient’s immune response to S. aureus infection.
  Study design: A prospective, observational, multicentre cohort study that will be conducted in hospitals distributed across Europe.

  Study participants: Adult patients (18 years of age or older) undergoing 1 or more of the protocol-listed surgical procedures are eligible but enrolment in the study cohort population will be based on preoperative S. aureus colonisation. In total, approximately 3300 S. aureus colonised subjects and 1700 non-colonised patients will be enrolled in the study out of these, 825 patients will be from the UK. These patients will be followed for up to 90 days from the day of surgery to assess study outcomes.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  17/WM/0311

• Date of REC Opinion

  20 Sep 2017

• REC opinion

  Further Information Favourable Opinion