Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

28. april 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5004

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UMC Utrecht

Samarbejdspartnere

MedImmune LLC

Efterforskere

  • Ledende efterforsker: Jan AJW Kluytmans, MD PhD, UMC Utrecht

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2016

Primær færdiggørelse (Faktiske)

1. november 2019

Studieafslutning (Faktiske)

1. januar 2020

Datoer for studieregistrering

Først indsendt

20. juli 2016

Først indsendt, der opfyldte QC-kriterier

12. oktober 2016

Først opslået (Skøn)

17. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL57595.041.16

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Staphylococcus Aureus

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner