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Staphylococcus Aureus Bacteraemia in Adults (ISAC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Cologne.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Achim Kaasch, University of Cologne
ClinicalTrials.gov Identifier:
NCT02098850
First received: March 25, 2014
Last updated: December 2, 2014
Last verified: December 2014
  Purpose
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.

Condition
Staphylococcus Aureus Bacteremia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Prospective International Study of Staphylococcus Aureus Bacteraemia in Adults by the International Staphylococcus Aureus Collaboration

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Mortality [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient in tertiary care hospitals
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098850

Locations
Germany
Uniklinik Koln
Cologne, NRW, Germany, 50935
Uniklinik Freiburg
Freiburg, Germany, 79106
Univeritatklinikum Schleswig-Holstein
Lübeck, Germany, 23562
Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Spain
Hospital San Pau
Barcelona, Spain, 08026
University Hospital Clinic de Barcelona
Barcelona, Spain, 08028
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Son Espases
Palma. Mallorca, Spain, 79 07120
Salamanca Hospital
Salamanca, Spain
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41007
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B9 5SS
Brighton and Sussex University Hospitals
Brighton, United Kingdom, BN2 5BE
Cambridge University Hospitals
Cambridge, United Kingdom, CB2 0QQ
Hull and East Yorkshire Hospitals
Hull, United Kingdom, HU3 2JZ
Royal Liverpool and Broadgreen Hospital
Liverpool, United Kingdom, L7 8XP
Royal Free Hospital
London, United Kingdom, NW3 2QG
Guy's and St Thomas'
London, United Kingdom, SE1 7EH
Kings College Hospital
London, United Kingdom, SE5 9RS
University College London Hospital
London, United Kingdom, WC1E 6AG
Oxford University Hospitals
Oxford, United Kingdom, OX3 9DU
Plymouth Hospitals
Plymouth, United Kingdom, PL6 8DH
Portsmouth Hospitals
Portsmouth, United Kingdom, PO3 6AD
Sponsors and Collaborators
University of Cologne
Investigators
Study Chair: Achim J Kaasch, MD University of Cologne
  More Information

Publications:
Responsible Party: Achim Kaasch, Dr. Achim Kaasch, University of Cologne
ClinicalTrials.gov Identifier: NCT02098850     History of Changes
Other Study ID Numbers: ISAC-01 
Study First Received: March 25, 2014
Last Updated: December 2, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
Staphylococcus aureus
bloodstream infection
bacteremia

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016