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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02098850
Other study ID # ISAC-01
Secondary ID
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


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
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