Clinical trial NCT02098850: Staphylococcus Aureus Bacteraemia in Adults
Official title: A Prospective International Study of Staphylococcus Aureus Bacteraemia in Adults by the International Staphylococcus Aureus Collaboration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus Bacteremia
Keywords: Staphylococcus aureus
bloodstream infection
bacteremia
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in tertiary care hospitals

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 90 Days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 90 Days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Uniklinik Koln
state: NRW
city: Freiburg
country: Germany
facility: Uniklinik Freiburg
city: Lübeck
country: Germany
facility: Univeritatklinikum Schleswig-Holstein
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Barcelona
country: Spain
facility: Hospital San Pau
city: Barcelona
country: Spain
facility: University Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Palma. Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Salamanca
country: Spain
facility: Salamanca Hospital
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: West Midlands
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas'
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals
Study officials:
affiliation: University of Cologne
name: Achim J Kaasch, MD
role: STUDY_CHAIR
References:
citation: Kaasch AJ, Barlow G, Edgeworth JD, Fowler VG Jr, Hellmich M, Hopkins S, Kern WV, Llewelyn MJ, Rieg S, Rodriguez-Bano J, Scarborough M, Seifert H, Soriano A, Tilley R, Torok ME, Weiss V, Wilson AP, Thwaites GE; ISAC, INSTINCT, SABG, UKCIRG, and Colleagues. Staphylococcus aureus bloodstream infection: a pooled analysis of five prospective, observational studies. J Infect. 2014 Mar;68(3):242-51. doi: 10.1016/j.jinf.2013.10.015. Epub 2013 Nov 16.