Staphylococcus Aureus Bacteraemia in Adults

Staphylococcus Aureus Bacteremia Clinical Trial

— ISAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098850
• Other study ID #: ISAC-01
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2014
• Last updated: December 2, 2014
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: University of Cologne
• Contact: Achim J Kaasch, MD
• Phone: +4922147832100
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcus Aureus Bacteremia

Locations

Country	Name	City	State
Germany	Uniklinik Koln	Cologne	NRW
Germany	Uniklinik Freiburg	Freiburg
Germany	Univeritatklinikum Schleswig-Holstein	Lübeck
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Spain	Hospital San Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	University Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Son Espases	Palma. Mallorca
Spain	Salamanca Hospital	Salamanca
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Taiwan	Far Eastern Memorial Hospital	New Taipei City
United Kingdom	Birmingham Heartlands Hospital	Birmingham	West Midlands
United Kingdom	Brighton and Sussex University Hospitals	Brighton
United Kingdom	Cambridge University Hospitals	Cambridge
United Kingdom	Hull and East Yorkshire Hospitals	Hull
United Kingdom	Royal Liverpool and Broadgreen Hospital	Liverpool
United Kingdom	Guy's and St Thomas'	London
United Kingdom	Kings College Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Oxford University Hospitals	Oxford
United Kingdom	Plymouth Hospitals	Plymouth
United Kingdom	Portsmouth Hospitals	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Countries where clinical trial is conducted

Germany,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

References & Publications (1)

Kaasch AJ, Barlow G, Edgeworth JD, Fowler VG Jr, Hellmich M, Hopkins S, Kern WV, Llewelyn MJ, Rieg S, Rodriguez-Baño 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. Erratum in: J Infect. 2014 Sep;69(3):306-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		90 Days	No
Secondary	Length of hospital stay		90 Days	No