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Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections (ASPIRE-SSI)

28. april 2021 oppdatert av: Jan Kluytmans, UMC Utrecht
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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

5004

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Gent, Belgia
        • Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent
      • Lier, Belgia
        • H. Hartziekenhuis
  • Estland
      • Tallin, Estland
        • North Estonia Medical Centre
      • Tartu, Estland
        • Tartu University Clinic
  • Frankrike
      • Limoges, Frankrike
        • Centre Hospitalier Universitaire de Limoges
  • Italia
      • Ancona, Italia
        • Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona
      • Brescia, Italia
        • Brescia Hospital
      • Rimini, Italia
        • Ospedale Infermi di Rimini
  • Nederland
      • Assen, Nederland
        • Wilhemina Ziekenhuis Assen
      • Breda, Nederland
        • Amphia Hospital
      • Utrecht, Nederland
        • UMC Utrecht
  • Romania
      • Bukarest, Romania
        • Carol Davila University of Medicine and Pharmacy Bucharest
      • Bukarest, Romania
        • Elias University Emergency Hospital
      • Bukarest, Romania
        • Prof. C.C. Iliescu Cardiovascular Diseases Institute
      • Timişoara, Romania
        • Clinic County Hospital Timisoara
  • Serbia
      • Belgrad, Serbia
        • Clinical Centre of Serbia
      • Belgrad, Serbia
        • Institute for Orthopedic Surgery Banjica
      • Kragujevac, Serbia
        • Clinical Centre of Kragujevac
  • Spania
      • Barcelona, Spania
        • Hospital Universitari de Bellvitge
      • Cadiz, Spania
        • Hospital Universitari del Mar
      • Córdoba, Spania
        • HU Reina Sophia
      • Oviedo, Spania
        • Hospital Universitario Central de Asturias
      • Sevilla, Spania
        • Hospital Universitario Virgen Macarena
  • Storbritannia
      • Birmingham, Storbritannia
        • Queen Elizabeth Hospital
      • Brighton, Storbritannia
        • Brighton & Sussex University Hospital NHS Trust
      • Derby, Storbritannia
        • Derby Teaching Hospitals NHS Foundation Trust
      • Manchester, Storbritannia
        • The Pennine Acute Hospitals NHS Trust Manchester
      • Middlesbrough, Storbritannia
        • South Tees Hospitals NHS Foundation Trust
      • York, Storbritannia
        • York Teaching Hospitals NHS Foundation Trust
  • Tsjekkia
      • Brno Střed, Tsjekkia
        • St. Anne's University Hospital Brno
      • Nový Hradec Králové, Tsjekkia
        • University hospital Hradec Králové
      • Ostrava, Tsjekkia
        • University Hospital Ostrava
      • Praha, Tsjekkia
        • University Hospital Motol

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients undergoing 1 of the protocol-defined surgical procedures are eligible for inclusion in the study. However, enrolment in the study cohort population will be based on preoperative S. aureus colonization. In total, approximately 3300 S. aureus colonized subjects and 1700 non-colonized subjects will be enrolled in the study cohort population.

Protocol-defined surgical procedures: Coronary artery bypass grafting; ICD implantation; knee and hip prosthesis surgery; laminectomy and spinal fusion surgery; emergency surgery; central artery reconstructive and peripheral artery bypass surgery; mastectomy; and craniotomy.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of S. aureus SSI
Tidsramme: Up to 90 days following surgery.
Up to 90 days following surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI)
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus bloodstream infection
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of other post-surgical S. aureus infection
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of all-cause SSI, by etiologic agent
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI stratified by antibiotic susceptibility
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Prevalence of preoperative S. aureus colonization in nose, throat and perineal region.
Tidsramme: No more than 30 days prior to surgery
No more than 30 days prior to surgery
Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of post-surgical all-cause mortality
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Semi-quantification of the bacterial load of colonizing S. aureus
Tidsramme: At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Characterization of S. aureus isolates involved in colonization
Tidsramme: 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
At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery)
Serum antibody levels against S. aureus virulence factors.
Tidsramme: Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample)
Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample)
Characterization of S. aureus isolates involved in infections
Tidsramme: Up to 90 days following surgery
Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates
Up to 90 days following surgery

Andre resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by participating country
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by type of surgery
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by wound classification
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by urgency of surgery
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery
Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification
Tidsramme: Up to 90 days following surgery
Up to 90 days following surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UMC Utrecht

Samarbeidspartnere

MedImmune LLC

Etterforskere

  • Hovedetterforsker: Jan AJW Kluytmans, MD PhD, UMC Utrecht

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2016

Primær fullføring (Faktiske)

1. november 2019

Studiet fullført (Faktiske)

1. januar 2020

Datoer for studieregistrering

Først innsendt

20. juli 2016

Først innsendt som oppfylte QC-kriteriene

12. oktober 2016

Først lagt ut (Anslag)

17. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL57595.041.16

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Nei

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