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Clinical Trials/NCT02098850
NCT02098850UnknownNot Applicable

A Prospective International Study of Staphylococcus Aureus Bacteraemia in Adults by the International Staphylococcus Aureus Collaboration

University of Cologne24 sites in 5 countries2,000 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
2,000
Locations
24
Primary Endpoint
Mortality

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 90 Days

Secondary Outcomes

  • Length of hospital stay(90 Days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Achim Kaasch

Dr. Achim Kaasch

University of Cologne

Study Sites (24)

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