Staphylococcus Aureus Bacteraemia in Adults (ISAC)

December 2, 2014 updated by: Achim Kaasch, University of Cologne

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, 79106
        • Recruiting
        • Uniklinik Freiburg
        • Contact:
          • Siegbert Rieg, MD
      • Lübeck, Germany, 23562
        • Recruiting
        • Univeritatklinikum Schleswig-Holstein
        • Contact:
          • Jan Rupp, MD
    • NRW
      • Cologne, NRW, Germany, 50935
        • Recruiting
        • Uniklinik Koln
        • Contact:
        • Principal Investigator:
          • Achim J Kaasch, MD
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Hong Bin Kim
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
          • Benito Almirante, MD
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital San Pau
        • Contact:
          • Mercedes Gurgui Ferrer, MD
      • Barcelona, Spain, 08028
        • Recruiting
        • University Hospital Clínic de Barcelona
        • Contact:
          • Alex Soriano, MD
      • Palma. Mallorca, Spain, 79 07120
        • Recruiting
        • Hospital Universitario Son Espases
        • Contact:
          • Jose Luis Perez Saenz, MD
      • Salamanca, Spain
        • Recruiting
        • Salamanca Hospital
        • Contact:
          • Hugo Guillermo Ternavasio-de la Vega, MD
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Luis Edwardo Lopez-Cortes, MD
      • Sevilla, Spain, 41007
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Jesus Rodriguez-Bano, MD
  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:
          • Chun-Hsing Liao
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • Brighton and Sussex University Hospitals
        • Contact:
          • Martin Llewelyn, MD
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals
        • Contact:
          • Estee Torok, MD
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • Hull and East Yorkshire Hospitals
        • Contact:
          • Gavin Barlow, MD
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool and Broadgreen Hospital
        • Contact:
          • Emmanuel Nsutebu, MD
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Kings College Hospital
        • Contact:
          • Dakshika Jeyaratnam, MD
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
          • Susan Hopkins, MD
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St Thomas'
        • Contact:
          • Jonathan Edgeworth, MD
      • London, United Kingdom, WC1E 6AG
        • Recruiting
        • University College London Hospital
        • Contact:
          • Peter Wilson, MD
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals
        • Contact:
          • Matthew Scarborough, MD
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Plymouth Hospitals
        • Contact:
          • Robert Tilley, MD
      • Portsmouth, United Kingdom, PO3 6AD
        • Recruiting
        • Portsmouth Hospitals
        • Contact:
          • Sarah Wyllie, MD
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Recruiting
        • Birmingham Heartlands Hospital
        • Contact:
          • Das Pillay, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient in tertiary care hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 90 Days
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 90 Days
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Study Chair: Achim J Kaasch, MD, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISAC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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