Staphylococcus Aureus Bacteraemia in Adults

NCT ID: NCT02098850

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Staphylococcus Aureus Bacteremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Achim Kaasch

Dr. Achim Kaasch

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Achim J Kaasch, MD

Role: STUDY_CHAIR

University of Cologne

Locations

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Uniklinik Koln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Uniklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Univeritatklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital San Pau

Barcelona, , Spain

Site Status RECRUITING

University Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Son Espases

Palma. Mallorca, , Spain

Site Status RECRUITING

Salamanca Hospital

Salamanca, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Birmingham Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Brighton and Sussex University Hospitals

Brighton, , United Kingdom

Site Status RECRUITING

Cambridge University Hospitals

Cambridge, , United Kingdom

Site Status RECRUITING

Hull and East Yorkshire Hospitals

Hull, , United Kingdom

Site Status RECRUITING

Royal Liverpool and Broadgreen Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Guy's and St Thomas'

London, , United Kingdom

Site Status RECRUITING

Kings College Hospital

London, , United Kingdom

Site Status RECRUITING

University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Oxford University Hospitals

Oxford, , United Kingdom

Site Status RECRUITING

Plymouth Hospitals

Plymouth, , United Kingdom

Site Status RECRUITING

Portsmouth Hospitals

Portsmouth, , United Kingdom

Site Status RECRUITING

Countries

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Germany South Korea Spain Taiwan United Kingdom

Central Contacts

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Achim J Kaasch, MD

Role: CONTACT

+4922147832100

Christian M Bernasch

Role: CONTACT

Facility Contacts

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Achim J Kaasch, MD

Role: primary

+4922147832022

Siegbert Rieg, MD

Role: primary

Jan Rupp, MD

Role: primary

Hong Bin Kim

Role: primary

Mercedes Gurgui Ferrer, MD

Role: primary

Alex Soriano, MD

Role: primary

Benito Almirante, MD

Role: primary

Jose Luis Perez Saenz, MD

Role: primary

Hugo Guillermo Ternavasio-de la Vega, MD

Role: primary

Jesus Rodriguez-Bano, MD

Role: primary

Luis Edwardo Lopez-Cortes, MD

Role: primary

Chun-Hsing Liao

Role: primary

Das Pillay, MD

Role: primary

Martin Llewelyn, MD

Role: primary

Estee Torok, MD

Role: primary

Gavin Barlow, MD

Role: primary

Emmanuel Nsutebu, MD

Role: primary

Susan Hopkins, MD

Role: primary

Jonathan Edgeworth, MD

Role: primary

Dakshika Jeyaratnam, MD

Role: primary

Peter Wilson, MD

Role: primary

Matthew Scarborough, MD

Role: primary

Robert Tilley, MD

Role: primary

Sarah Wyllie, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24247070 (View on PubMed)

Other Identifiers

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ISAC-01

Identifier Type: -

Identifier Source: org_study_id