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NCT Number: NCT02935244

Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

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.

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Staphylococcal Infections Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of S. aureus SSI

    Time frame: Up to 90 days following surgery.

Secondary outcomes

  1. Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)

    Time frame: Up to 90 days following surgery

  2. Incidence of S. aureus bloodstream infection

    Time frame: Up to 90 days following surgery

  3. Incidence of other post-surgical S. aureus infection

    Time frame: Up to 90 days following surgery

  4. Incidence of all-cause SSI, by etiologic agent

    Time frame: Up to 90 days following surgery

  5. Incidence of S. aureus SSI stratified by antibiotic susceptibility

    Time frame: Up to 90 days following surgery

  6. Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.

    Time frame: No more than 30 days prior to surgery

  7. Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization

    Time frame: Up to 90 days following surgery

  8. Incidence of post-surgical all-cause mortality

    Time frame: Up to 90 days following surgery

  9. 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)

  10. 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)

    Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates

  11. 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)

  12. Characterization of S. aureus isolates involved in infections

    Time frame: Up to 90 days following surgery

    Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates

Other outcomes

  1. Magnitude of healthcare utilization associated with S. aureus SSI in terms of: a. Duration of length of stay (LOS) b. Incidence of readmissions, including re-interventions due to S. aureus SSI c. Duration of LOS during readmissions

    Time frame: Up to 90 days following surgery

  2. Incidence of S. aureus SSI, stratified by participating country

    Time frame: Up to 90 days following surgery

  3. Incidence of S. aureus SSI, stratified by type of surgery

    Time frame: Up to 90 days following surgery

  4. Incidence of S. aureus SSI, stratified by wound classification

    Time frame: Up to 90 days following surgery

  5. Incidence of S. aureus SSI, stratified by urgency of surgery

    Time frame: Up to 90 days following surgery

  6. Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification

    Time frame: Up to 90 days following surgery

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • MedImmune LLC

Registry information

Acronym: ASPIRE-SSI

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 17, 2016
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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