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Trial record 36 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187134
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
Frank Bloos, Center for Sepsis Control and Care, Germany

Brief Summary:

Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent studies showed that such treatment is delayed for several hours.

In this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. Tools of change management are used. The data are compared to a control group (hospitals without intervention).

It is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.

Condition or disease Intervention/treatment Phase
Sepsis Shock, Septic Behavioral: Change Management Not Applicable

Detailed Description:

This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany have confirmed their participation. Hospitals are randomized into two groups: a control and an interventional group. The control group receives conventional CMEs. The interventional group receives tools for increasing awareness such as posters and brochures. Quality measure such as benchmarking and feedback of quality indicators are used. Depending on the improvement process tools such as SWOT analyses and resistance radar will be implemented.

The CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. These data are used for final sample size calculation of the CRT and for stratification of the randomization.

The groups switch after completion of the CRT and observation continues. Thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. This study phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT has been finished.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Medical Education for Sepsis Source Control and Antibiotics
Study Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intervention group Behavioral: Change Management
Hospitals have to create local change teams which are supported and trained by the study center. Local awareness of the staff is increased by PowerPoint presentations, posters, and brochures. The change teams receive monthly information about their quality indicator (duration until antimicrobial therapy). Anonymous comparison to other hospitals is possible (Benchmarking). Hospitals are visited three times a year to discuss progress of quality. In case of failure to improve, the change team is supported with specific tools for change management such as SWOT-analysis or resistance radar.

No Intervention: Conventional CME
Hospitals receive conventional continuing medical education in lecture style twice a year. They receive current publications and recommendations for national and international meetings regarding diagnosis and therapy of sepsis.

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Fraction of patients with antimicrobial therapy within 1 hour
  2. Duration until antimicrobial therapy
  3. Duration until focus control
  4. Frequency of blood cultures
  5. Frequency of adequate antimicrobial therapy
  6. ICU and hospital mortality
  7. ICU and and hospital length of stay

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. For the hospitals (cluster):

    • Involved in the primary care of patients with severe sepsis/septic shock
    • Willing to participate in a guideline implementation process
  2. For the patients:

    • New onset of suspicion of severe sepsis or septic shock in the following settings:

      1. Prehospital
      2. Emergency department
      3. Operating theatre
      4. Regular ward
      5. Intensive care unit (ICU)/Intermediate Care Unit (IMC)

Exclusion Criteria:

  1. For the hospitals (cluster):

    • No intensive care unit available
    • no acute care for patients with severe sepsis and septic shock
  2. For the patients:

    • Start of sepsis therapy in a non-study site
    • Patients not admitted to the ICU/IMC
    • No commitment to full medical support (i.e. DNR)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187134

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Universitätklinikum Aachen
Aachen, Germany
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
Arnstadt, Germany
HELIOS Klinikum Aue
Aue, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Hufelandkrankenhaus GmbH
Bad Langensalza, Germany
Bundeswehrkrankenhaus Berlin
Berlin, Germany
Charité Berlin
Berlin, Germany
HELIOS Kliniken Berlin-Buch
Berlin, Germany
HELIOS Klinikum Emil von Behring
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Ev. Krankenhaus Bielefeld
Bielefeld, Germany
HELIOS St. Josefs-Hospital Bochum-Linden
Bochum, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
St. Georg Klinikum Eisenach gGmbH
Eisenach, Germany
Waldkrankenhaus Rudolf Elle GmbH
Eisenberg, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Katholisches Krankenhaus St. Johann Nepomuk
Erfurt, Germany
Bürgerhospital Friedberg
Friedberg, Germany
SRH Waldklinikum Gera
Gera, Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Germany
Klinik am Eichert
Göppingen, Germany
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
Ilmenau, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Kiel
Kiel, Germany
HELIOS-Klinikum Krefeld GmbH
Krefeld, Germany
Krankenhaus Landshut-Achdorf
Landshut, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum Meiningen GmbH
Meiningen, Germany
Saale-Unstrut-Klinikum Naumburg
Naumburg, Germany
Südharz-Krankenhaus Nordhausen gGmbH
Nordhausen, Germany
Klinikum Oldenburg
Oldenburg, Germany
Thüringen-Klinik Pößneck gGmbH
Pößneck, Germany
ASKLEPIOS-ASB Krankenhaus Radeberg GmbH
Radeberg, Germany
Thüringen-Kliniken "Georgius Agricola" GmbH
Saalfeld, Germany
Klinikum Saarbrücken gGmbH
Saarbrücken, Germany
Diakonie-Klinikum Schwäbisch-Hall gGmbH
Schwäbisch-Hall, Germany
Ev. Jung-Stilling-Krankenhaus
Siegen, Germany
SRH Zentralklinikum Suhl GmbH
Suhl, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Sophien- und Hufeland-Klinikum gGmbH
Weimar, Germany
HELIOS Klinikum Wuppertal
Wuppertal, Germany
Sponsors and Collaborators
Center for Sepsis Control and Care, Germany
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Principal Investigator: Reinhart Konrad, MD Jena University Hospital, Germany
Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital

Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Frank Bloos, Lead investigator of the MEDUSA study group, Center for Sepsis Control and Care, Germany Identifier: NCT01187134     History of Changes
Other Study ID Numbers: C1.1
01EO1002 ( Other Grant/Funding Number: Federal Ministry of Education and Research (BMBF) of Germany )
U1111-1118-2850 ( Other Identifier: WHO Universal Trial Number )
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Frank Bloos, Center for Sepsis Control and Care, Germany:
shock, septic
quality assurance, health care
quality control
Survival Rate
Follow-Up Studies
Anti-Infective Agents/*therapeutic use
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents