Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
NCT03353532
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Adult Trials: 18+ Years
- Age ≥18 years at the time of surgery
- Cases with missing data defined as "missing completely at random" (MCAR)
- Infection at the time of surgery
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| Descriptive Information | |||||
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| 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:
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| 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 |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| 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 | 200000 | ||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Oliver Cornely, MD, University of Cologne | ||||
| Study Sponsor | University of Cologne | ||||
| Collaborators | Pfizer | ||||
| Investigators |
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| PRS Account | University of Cologne | ||||
| Verification Date | September 2019 | ||||