Staphylococcus Aureus Bacteraemia in Adults

• Conditions: Staphylococcus Aureus Bacteremia

• Registration Number: NCT02098850
• Lead Sponsor: University of Cologne

Brief Summary

The purpose of this evaluation is to record the management and outcome of adults with S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to identify key quality indicators associated with improved outcome.

Detailed Description

Staphylococcus aureus (S. aureus) is one of the most common causes of bloodstream infections. Associated mortality has been reported to vary widely (4%-40%) although no obvious explanation for such variation has been identified.

Despite the existence of clinical guidelines, there is considerable variation in the management of S.aureus bacteraemia (SAB) between centres. Part of the variation in clinical management is due to the limited evidence base defining optimal therapy. Fewer than 1500 patients have been recruited to randomised controlled trials in the past 40 years; practice is therefore based largely on experience and observational studies.

The purpose of this evaluation is to record the management and outcome of adults with SAB across multiple European, Asian and North American sites. We aim to establish a broader knowledge base, identify key quality indicators associated with improved outcomes, and to provide comparator data to ensure that patients enrolled in randomized controlled trials are representative of bacteraemic S. aureus patients as a whole. All participating centres are experienced in the management of S. aureus bacteraemia and in conducting evaluations of current management practice and outcomes from S. aureus bacteraemia. Data is checked for plausibility by a centralized data quality control group.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03
• Primary Completion: 2015-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• S. aureus (methicillin sensitive or resistant) isolated from one or more blood cultures

Exclusion Criteria

• Recurrent episodes of S. aureus bloodstream infection
• Polymicrobial infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	90 Days

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	90 Days

Trial Locations

Locations (24)

Uniklinik Koln; 🇩🇪 Cologne, NRW, Germany

Uniklinik Freiburg; 🇩🇪 Freiburg, Germany

Univeritatklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital San Pau; 🇪🇸 Barcelona, Spain

University Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma. Mallorca, Spain

Salamanca Hospital; 🇪🇸 Salamanca, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

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