Trial document




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  DRKS00014320

Trial Description

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Title

A hospital-wide electronic medical record-based computerized decision support system to improve outcomes of patients with bloodstream infections

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Trial Acronym

HELP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with infections computerized decision-support systems (CDSS) may help to establish the correct diagnosis, to choose appropriate antimicrobial treatment and to balance optimal patient care with undesirable aspects, such as the development of antibiotic resistance, adverse events, and costs. The intended project aims for the development and implementation of a CDSS in patients with Staphylococcal bloodstream infection.

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Brief Summary in Scientific Language

In patients with infections computerized decision-support systems (CDSS) may help to establish the correct diagnosis, to choose appropriate antimicrobial treatment, and to balance optimal patient care with undesirable aspects, such as the development of antibiotic resistance, adverse events, and costs. The intended project aims for the development and implementation of a CDSS in patients with Staphylococcal bloodstream infection. The CDSS will guide physicians to adhere to best practice recommendations in the management of patients with Staphylococcus aureus or Staphylococcus lugdunensis bacteremia, including recommendations for early source identification and control, follow-up blood cultures, appropriate choice of antimicrobial substance and duration of therapy. In addition, the CDSS will guide physicians in the management of patients with growth of coagulase negative staphylococci in blood culture. The evaluation will be by stepped-wedge design.

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Organizational Data

  •   DRKS00014320
  •   2019/05/06
  •   [---]*
  •   yes
  •   Approved
  •   2018-1264-BO, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   A41.0 -  Sepsis due to Staphylococcus aureus
  •   A41.1 -  Sepsis due to other specified staphylococcus
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Interventions/Observational Groups

  •   HELP App (CDSS)
  •   TAU ("treatment as usual")
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Other
  •   Other
  •   Other
  •   N/A
  •   No
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Primary Outcome

Coprimary endpoints (confirmatory test in the hierarchical order given here):
- mortality and relapse rate due to S. aureus within 90 days in the SAB arm (non-inferiority test) and
- the cumulative consumption of vancomycin in the CNS arm (superiority test)

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Secondary Outcome

- acute renal failure (KDIGO clinical practice guideline for acute kidney injury)
- cumulative consumption of vancomycin, linezolid, teicoplanin, daptomycin, rifampicin, fosfomycin, flucloxacillin, cefazolin
- incoming blood culture sets per institution and year
- estimation of treatment costs based on ID consultation times and frequencies (only for complicated SAB) as well as technical and process-oriented endpoints from questionnaires (user survey)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/01
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Staphylococcus spp. bacteremia

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Institut für Infektionsmedizin und Krankenhaushygiene, Universitätsklinikum Jena
    • Mr.  Prof. Dr  Mathias  Pletz 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Institut für Medizinische Statistik, Informatik und Datenwissenschaften (IMSID), Universitätsklinikum Jena
    • Mr.  Prof. Dr.  André  Scherag 
    • Bachstrasse 18
    • 07743  Jena
    • Germany
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    • Institut für Medizinische Statistik, Informatik und Datenwissenschaften (IMSID), Universitätsklinikum Jena
    • Mr.  Prof. Dr.  André  Scherag 
    • Bachstrasse 18
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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