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Staphylococcus Aureus BacteremiaISACNCT02098850

Staphylococcus Aureus Bacteraemia in Adults

An observational study of Staphylococcus Aureus Bacteremia, run by University of Cologne at 24 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcus Aureus Bacteremia
How many people
2,000 participants
Where
24 sitesin 5 countries
Study dates
Jan 2013to May 2016
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient in tertiary care hospitals

Who may be able to join

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

Who cannot join

  • Recurrent episodes of S. aureus bloodstream infection
  • Polymicrobial infection

Trial locations and contacts

24 sites in 5 countries.

Achim J Kaasch, MD contact

+4922147832100

Christian M Bernasch contact

24 sites in 5 countries

United Kingdom12 sites, 12 recruiting

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

    Das Pillay, MD

    Recruiting

  • Brighton and Sussex University Hospitals

    Brighton, BN2 5BE

    Martin Llewelyn, MD

    Recruiting

  • Cambridge University Hospitals

    Cambridge, CB2 0QQ

    Estee Torok, MD

    Recruiting

  • Hull and East Yorkshire Hospitals

    Hull, HU3 2JZ

    Gavin Barlow, MD

    Recruiting

  • Royal Liverpool and Broadgreen Hospital

    Liverpool, L7 8XP

    Emmanuel Nsutebu, MD

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Susan Hopkins, MD

    Recruiting

  • Guy's and St Thomas'

    London, SE1 7EH

    Jonathan Edgeworth, MD

    Recruiting

  • Kings College Hospital

    London, SE5 9RS

    Dakshika Jeyaratnam, MD

    Recruiting

  • University College London Hospital

    London, WC1E 6AG

    Peter Wilson, MD

    Recruiting

  • Oxford University Hospitals

    Oxford, OX3 9DU

    Matthew Scarborough, MD

    Recruiting

  • Plymouth Hospitals

    Plymouth, PL6 8DH

    Robert Tilley, MD

    Recruiting

  • Portsmouth Hospitals

    Portsmouth, PO3 6AD

    Sarah Wyllie, MD

    Recruiting

Other trials in United Kingdom

Spain7 sites, 7 recruiting

  • Hospital San Pau

    Barcelona, 08026

    Mercedes Gurgui Ferrer, MD

    Recruiting

  • University Hospital Clinic de Barcelona

    Barcelona, 08028

    Alex Soriano, MD

    Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Benito Almirante, MD

    Recruiting

  • Hospital Universitario Son Espases

    Palma. Mallorca, 79 07120

    Jose Luis Perez Saenz, MD

    Recruiting

  • Salamanca Hospital

    Salamanca

    Hugo Guillermo Ternavasio-de la Vega, MD

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41007

    Jesus Rodriguez-Bano, MD

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Luis Edwardo Lopez-Cortes, MD

    Recruiting

Other trials in Spain

Germany3 sites, 3 recruiting

  • Uniklinik Koln

    Cologne, North Rhine-Westphalia, 50935

    Achim J Kaasch, MD, +4922147832022, achim.kaasch@uk-koeln.de

    Achim J Kaasch, MD

    Recruiting

  • Uniklinik Freiburg

    Freiburg im Breisgau, 79106

    Siegbert Rieg, MD

    Recruiting

  • Univeritatklinikum Schleswig-Holstein

    Lübeck, 23562

    Jan Rupp, MD

    Recruiting

Other trials in Germany

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seoul

    Hong Bin Kim

    Recruiting

Other trials in South Korea

Taiwan1 site, 1 recruiting

  • Far Eastern Memorial Hospital

    New Taipei City

    Chun-Hsing Liao

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Keywords
Staphylococcus aureus, bloodstream infection, bacteremia
Medical subject headings
Staphylococcal Infections, Sepsis, Bacteremia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 90 Days

Secondary outcomes (1)

  1. Length of hospital stay

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2015 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098850
Sponsor's protocol ID
ISAC-01
Acronym
ISAC
Status last verified
Dec 2014
First submitted
25 Mar 2014
Last updated
3 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24247070

Questions about this trial

What is this clinical trial studying?

An observational study of Staphylococcus Aureus Bacteremia, run by University of Cologne at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United Kingdom, Spain, Germany, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Achim J Kaasch, MD (+4922147832100), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.

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