Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

NCT03353532

Last updated date
Study Location
Centre Hospitalier Départemental Vendee
La Roche-sur-Yon, , , France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcus Aureus, Surgical Wound Infection, Epidemiology
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age ≥18 years at the time of surgery

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Cases with missing data defined as "missing completely at random" (MCAR)


- Infection at the time of surgery

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Staphylococcus Aureus, Surgical Wound Infection, EpidemiologyStaphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
NCT03353532
  1. La Roche-sur-Yon,
  2. Limoges,
  3. Tours,
  4. Cologne, NRW
  5. Bonn,
  6. Jena,
  7. Munich,
  8. Udine,
  9. Barcelona,
  10. Barcelona,
  11. Madrid,
  12. Madrid,
  13. Valencia,
  14. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
Official Title Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
Brief Summary

This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.

Data will be assessed in two populations.

Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.

Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.

If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.

The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.

Matching criteria comprise the following:

  • Type of procedure
  • Age
  • ASA score
  • BMI
  • Duration of procedure (as percentile for this procedure)
  • Diabetes
  • Sex
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with SSI after any surgical procedure
Condition
  • Staphylococcus Aureus
  • Wound Infection, Surgical
  • Epidemiology
Intervention Not Provided
Study Groups/Cohorts
  • Cohort
    Adult patients with SSI after any surgical procedure.
  • Case-Control

    Cases: Patients establishing S. aureus SSI Controls: Patients from the same center who did not undergo S. aureus SSI, matched by the following criteria

    • Type of procedure
    • Age
    • ASA score
    • BMI
    • Duration of procedure (as percentile for this procedure)
    • Diabetes
    • Sex
Publications * Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177. Erratum in: JMIR Res Protoc. 2019 Jan 07;8(1):e10712.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
200000
Original Estimated Enrollment
 (submitted: November 22, 2017)
150000
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ?18 years at the time of surgery

Exclusion Criteria:

  • Cases with missing data defined as "missing completely at random" (MCAR)
  • Infection at the time of surgery
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03353532
Other Study ID Numbers SALT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Oliver Cornely, MD, University of Cologne
Study Sponsor University of Cologne
Collaborators Pfizer
Investigators
Principal Investigator:Oliver A Cornely, MDUniversity of Cologne
PRS Account University of Cologne
Verification Date September 2019