Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007304

Trial Description

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Title

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

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Trial Acronym

ISAC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00007304
  •   2015/08/14
  •   2014/03/25
  •   yes
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Secondary IDs

  •   NCT02098850  (ClinicalTrials.gov)
  •   ISAC-01  (University of Cologne)
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Health Condition or Problem studied

  •   Staphylococcus Aureus Bacteremia
  •   A49.0 -  Staphylococcal infection, unspecified site
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Mortality; time frame: 90 Days

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Secondary Outcome

- Length of hospital stay; time frame: 90 Days

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Countries of Recruitment

  •   Germany
  •   Korea, Republic of
  •   Spain
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/01/31
  •   2000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- S. aureus (methicillin sensitive or resistant) isolated from one or more blood
cultures

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Exclusion Criteria

- Recurrent episodes of S. aureus bloodstream infection

- Polymicrobial infection

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Cologne
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    • University of Cologne
    • Achim J Kaasch, MD 
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    • Achim J Kaasch, MD 
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    •   +4922147832100
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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, Tőrők 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.; 24247070
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.