Trial document




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  DRKS00004825

Trial Description

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Title

Incidence of nosocomial blood stream infections, antibiotic resistances and blood culture ordering and testing practices – a Thuringia-wide prospective population-based study

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Trial Acronym

AlertsNet

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URL of the Trial

http://www.alertsnet.de/

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Brief Summary in Lay Language

The overriding aim of the project is the further development of quality assurance in blood culture diagnostics. This is to be achieved by ensuring that blood culture testing is conducted sufficiently often and as indicated. A state-wide surveillance system for blood stream infections (primary and secondary sepsis) including the registration of antimicrobial resistance will be established.
The network will comprise stationary institutions (hospitals and rehabilitation facilities), as well as all microbiological laboratories in the Free State of Thuringia. This will create a reference to the population as a whole and will produce data that is representative of the community for a population of more than 2.3 million people. An electronic reporting system will be developed that gathers reports on blood culture testing in a timely manner. The reporting system will also collect selected clinical details of patients with nosocomial blood stream infections in order to determine the extent to which mortality and morbidity are caused by antimicrobial resistance. The reporting system will enable the data to be fed back to participating institutions, so that short-term interventions for the benefit and improvement of quality will be possible. As an accompanying attempt during this step in the process, a standardized survey will be conducted in which staff are asked about the practice of blood culture testing in their hospitals, as this will allow observed differences to be classified more effectively. Adjusted reference values for the indicators are to be developed, as these will enable the indicator values in specific institutions to be interpreted. The reference values for incidence rates of blood culture sets that are drawn will be validated on the basis of an empirical analysis of the association between incidence rate and sepsis mortality in the participating institutions. The utilisation of quality assurance indicators, however, requires that characteristics of the specific institution are also included.

In a future trial (registered independently), the same participating facilities will be trained on the new indicators to proof their usefulness. An expected improvement in the values of the indicators will demonstrate the usefulness of surveillance (including educational measures) as a measure for quality assurance and for improving the quality of health care.

In the following it will be focused only onto the non-interventional study part.

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Brief Summary in Scientific Language

Principal aim is the further development of quality indicators for nosocomial blood stream infections, the establishment of an exemplary reporting system (as an evaluation study). A further trial (registered independently) will successively follow as an interventional study on the basis of the new/modified indicators.

1) Establish a state-wide warning system for nosocomial blood stream infections (quantitative collection of aggregated data; 2) generate indicators for quality assurance, 3) determine reference values, 4) quantitative data collection by surveying usual practice of blood culture testing at participating institutions, with possible supplemental data from a qualitative survey.

Reports are to be collected from participating institutions (aggregated data), primary data from a survey.
Eligible for participation are almost all clinics with blood culture diagnostics in Thuringia, e.g. ~38 clinical facilities and ~18 associated microbiological~ laboratory institutes.
The analysis takes place in three steps: 1) generate indicators, 2) determine reference values for the indicators after adjusting for hospital characteristics (reference values will be operationalised using the expected values of a Poisson distribution), 3) analysis of relationship between incidence rate of blood culture testing and mortality after adjusting for hospital characteristics.
The project has model character and can be implemented in other federal states at a later date. The developed indicator reference values will be transferable to other institutions. Materials for improving the quality of blood culture testing will be developed and tested within the scope of the project. At a later date, these can then be used by other institutions as and when required.

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Organizational Data

  •   DRKS00004825
  •   2013/04/19
  •   [---]*
  •   yes
  •   Approved
  •   3744-05/13, 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

  •   R65.0 -  Systemic Inflammatory Response Syndrome of infectious origin without organ failure
  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
  •   A41.0 -  Sepsis due to Staphylococcus aureus
  •   A41.1 -  Sepsis due to other specified staphylococcus
  •   A41.2 -  Sepsis due to unspecified staphylococcus
  •   A41.3 -  Sepsis due to Haemophilus influenzae
  •   A41.4 -  Sepsis due to anaerobes
  •   A41.5 -  Sepsis due to other Gram-negative organisms
  •   A41.8 -  Other specified sepsis
  •   A41.9 -  Sepsis, unspecified
  •   A41 -  Other sepsis
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Interventions/Observational Groups

  •   All Thuringian hospiatals with blood culture diagnostics can take part in the surveillance. Currently, 30 clinical facilities are involved as well as 16 microbiological labs. Population Basis will be achieved latest in 2018. All patients with positive blood culture results will be included. The facilities send their blood culture bottles to the associated microbiological labs. In the event of a positive result the findings will be sent back and the findings will be recorded at the data bank simultaneously. The clinic will be informed on the occasion of the positive finding automatically and will sent further case-related information to the data bank via an internet-based case report form. These patient-related information and further facility-related data together will then be epidemiologically exploited
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary goal is the development and explorative validation of adjusted indicators for quality assurance in case of bloodstream infection with an aim at sufficient and indication-related diagnostics.
The following indicators are to be evaluated under consideration of the specific characteristics and the case-mix in the clinical facilities:

To get an overview:
Incidence rate of all episodes with in minimum 1 positive blood culture / sepsis incident (number/1,000 patient days)
Incidence rate of all nosokomial episodes with in minimum 1 positive blood culture / sepsis incident (number/1,000 patient days).

In addition to the frequently used indicators that describe resistances to different bacteria in blood cultures in percentage terms, a number of further indicators are proposed:
Incidence rate of CVC-associated blood stream infections (primary sepsis) (number/1,000 CVC-days),
Incidence rate of urinary catheter-associated blood stream infections (secondary sepsis) (number/1,000 urinary catheter-days),
Incidence rate of ventilator-associated pneumonia and associated blood stream infections (secondary sepsis) (number/1,000 ventilation days),
Incidence rate of positive blood cultures (number/1,000 blood culture sets), and
Incidence rate of total number of blood culture sets taken (number/1,000 patient days and sending institution).

To capture the degree of antibiotic resistance:
Incidence rate of positive blood cultures with resistant pathogens (number/1,000 patient days),
Incidence rate of positive blood cultures in case of nosokomial bloodstream infection with resistant pathogens (number/1,000 patient days).

To determine process quality:
Incidence rate of blood culture sets totally taken (number/1,000 patient days and posting facility),
Number of patients with drawn blood culture sets (number/1,000 patient days),
Number of blood culture sets per episode and per patient (number/episode and patient).

The reference values for incidence rates of blood culture sets that are drawn will be validated on the basis of an empirical analysis of the association between incidence rate and sepsis mortality in the participating institutions. The incidence rate of blood culture testing plays a central role in quality assurance because it influences other indicators and can be directly controlled.

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Secondary Outcome

Linking of all stationary facilities and microbiological labs in Thuringia to get access to representative data of the residents of the federal state.
Development of an electronic detection system for a timely survey on data from blood culture diagnostics. Capture of selected clinical characteristics of patients with nosokomial bloodstream infection (primary and secondary sepsis) to describe the degree of sepsis-associated morbidity and mortality.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2013/09/01
  •   25000
  •   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

Patients with positive blood culture

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Exclusion Criteria

None

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Addresses

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    • Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC), Universitätsklinikum Jena
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie (TMASGFF)
    • Werner-Seelenbinder-Straße 6
    • 99096  Erfurt
    • Germany
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    • Thüringer Landesamt für Lebensmittelsicherheit und Verbraucherschutz
    • Tennstedter Str. 8/9
    • 99947  Bad Langensalza
    • Germany
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    • Friedrich-Schiller-Universität Jena Institut für Medizinische Mikrobiologie
    • Ms.  Univ.-Prof. Dr. med.  Bettina   Löffler 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Zentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Univ.-Prof. Dr. med.  Matthias  Pletz 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Landesärztekammer Thüringen
    • Im Semmicht 33
    • 07751  Jena-Maua
    • Germany
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    • Zentrum für Klinische Studien, Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC), Universitätsklinikum Jena
    • Mr.  Univ.-Prof. Dr. med.   Frank Martin   Brunkhorst 
    • Salvador-Allende-Platz 27
    • 07747  Jena
    • Germany
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    • Klinische Epidemiologie, Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC), Universitätsklinikum Jena
    • Mr.  Univ.-Prof. Dr. physiol.  André  Scherag 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC), Universitätsklinikum Jena
    • Mr.  Dr. rer. nat.  Roland  Schmitz 
    • Salvador-Allende-Platz 27
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    • Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie (TMASGFF)
    • 99106   Erfurt
    • Germany
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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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