Trial document




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  DRKS00010135

Trial Description

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Title

Study on the utility of a statewide counseling program for improving outcomes of patients with staphylococcal bacteremia in Thuringia (SUPPORT)- a single blinded cluster randomized cross over trial

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Trial Acronym

SUPPORT

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URL of the Trial

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Brief Summary in Lay Language

Blood stream infections with S.aureus are severe infections that are associated with a high mortality rate. Treatment of the disease is complex and long-lasting. There is preliminary evidence from retrospektive trials and case series that infectious disease consultation improves the outcome of patients with SAB. In contrast to other countries, there are only few clinical infectious disease specialists working in Germany. For example, in the federal state of Thuringia with 2,2 Mio inhabitants, there are only 3 ID specialists working in hospitals.
A majority of patients is treated in small and medium sized hospitals that do not have access to ID specialist consultation.
With the SUPPORT trial we aim at investigating whether an ID specialist telephone counseling program can reduce the mortality rate of patients with SAB in Thuringia by pointing to a bundle of evidence-based quality-of-care indicators (QCIs).

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Brief Summary in Scientific Language

Staphylococcus aureus is one of the leading causes of bloodstream infections worldwide and hence cause significant morbidity, mortality, and health care costs. Unpublished data from the Alerts trial (PI Prof. FM Brunkhorst, University Hospital Jena, Germany) reveal an 25% in-hospital mortality of patients with Stapyhlococcus aureus bacteremia.
Preliminary evidence from non-randomized trials suggests that when an infectious diseases (ID) specialist is involved in a patient’s care and the physician in charge follows ID recommendations improves the quality of care and the outcome of the patients. However, evidence from randomized controlled trials is lacking, which limits the validity of the conclusions. This fact, aggravated by the threat of increasing antimicrobial resistance, has also been acknowledged by the German Infection Protection Act (“Infektionsschutzgesetz”), which calls for specialists to counsel primary care physicians in the treatment of infectious diseases. However, the majority of patients are hospitalized in small and medium-sized community and rural hospitals, which do not have access to bedside ID consultation due to shortage of ID specialists. In Thuringia, for example, there are only three certified ID specialists. Hence, unsolicited telephone consultation by an ID specialist may be an option to substantially improve patient care in the current setting. With the SUPPORT trial we aim at investigating whether an ID specialist telephone counseling program can improve the survival of patients with SAB in Thuringia by pointing to a bundle of evidence-based quality-of-care indicators (QCIs). This is also the first randomized controlled multi-center trial investigating the impact of ID counseling for patients with SAB in Thuringia.
We will include a total of 500 patients in at least 15 out of 34 hospitals participating in the federal state wide blood culture registry AlertsNet (PI Prof. FM Brunkhorst, University Hospital Jena, Germany, DRKS00004825). Participating hospitals will be randomized in two groups and two sequences: A-B or B-A. A is the intervention phase in which the treating physicians will receive unsolicited counseling. B is the observation phase in which no counseling will take place (standard of care). Groups will be switched after one year or after inclusion of 15 patients at the given hospital.

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Organizational Data

  •   DRKS00010135
  •   2016/05/02
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  •   yes
  •   Approved
  •   4608-11/15, 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
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Interventions/Observational Groups

  •   Standard of care: no unsolicted infectious disease consultation (15 patients per study center, maximum duration of recruitment 1 year. Then switch of the groups).
  •   unsolicited telephone infectious disease consultation by an infectious diseases specialist (15 patients per study center, maximum duration of recruitment 1 year. Then switch of the groups).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Control group receives no treatment
  •   Prognosis
  •   Crossover
  •   III
  •   N/A
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Primary Outcome

30 day mortality

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Secondary Outcome

adherence to 6 defined quality of care indicators for the treatment of S.aureus bacteremia until hospital discharge.
90-day all-cause mortality
90-day recurrence rate
Progression into Sepsis/Septic Shock during 90 days
Development of secundary septic foci during 90 days

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/07/21
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

documented SAB (staphylococcus aureus bacteremia);
written informed consent

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Exclusion Criteria

Positive blood cultures with other bacteria then S.aureus only; S.aureus infection without bacteremia; patients with limited treatment or end of treatment; patients with a life expectancy <90 days; patients with palliative care

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Addresses

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    • Center for Sepsis Care and Control
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen, Universitätsklinikum Jena
    • Mr.  Dr.med.  Sebastian  Weis 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Integriertes Forschungs- und BehandlungszentrumSepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Mr.  Dr.med.  Sebastian  Weis 
    • Am Klinikum 1
    • 07747  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 complete, follow-up complete
  •   2019/03/22
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.