Trial document




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  DRKS00004603

Trial Description

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Title

Epidemiology of MRSA in HCW in acute care facilities in comparison to the epidemiology of MRSA in HCW in long-term care facilities

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Trial Acronym

EMP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

About one third of the general population is colonized by Staphylococcus aureus, a normally harmless bacterium. This microorganism is able to obtain several resistance genes to antibiotics; this fact may complicate the treatment of infections. Health care workers (physicians, nurses, emergency medical service) are at higher risk than the general public. We will determinate the frequency of the colonization in this study, we will plan to include 2100 subjects. We provided an amendment reagarding an increase of subjects up to 3000 to ethics committee Greifswald on 23 June 2014, in order to assure a higher reliability of the data. MRSA-positive health care workes get an eradication cycle.

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Brief Summary in Scientific Language

Staphylococcus aureus (SA) is a gram-positive bacterium colonizing skin and nares of circa one third of the general population. Infections are even possible, like folliculitis, severe septic or toxin-mediated complications. The increased usage of antibiotics exerts an additional selection pressure on SA causing resistance to certain antibiotics, especially resistance to ß-lactamase antibiotics. Such a variant is called methicillin-resistant SA (MRSA). Nowadays, the term multi-resistant SA is more appropriate because of the acquisition of further resistance genes.
Health care workers (HCW) are at higher risk than the general public during their operational function. We will determinate the frequency of the colonization of HCWs and we will plan to include 2100 subjects. We provided an amendment reagarding an increase of subjects up to 3000 to ethics committee Greifswald on 23 June 2014, in order to assure a higher reliability of the data.

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Organizational Data

  •   DRKS00004603
  •   2013/01/03
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  •   yes
  •   Approved
  •   BB111/12, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  •   U1111-1137-8649 
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Health Condition or Problem studied

  •   U80.0 -  Penicillin resistant agent
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Interventions/Observational Groups

  •   detection of MRSA carriership, positive HCWs gain an eradication cycle
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prevalence of MRSA in several groups of HCWs

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Secondary Outcome

Rate of successful eradication, clonal patterns

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2013/05/14
  •   3000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Health care worker from 18 -65, informed consent

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Exclusion Criteria

no adequate comprehension of German, participation in another trial, intolerance to eradication medicine

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Addresses

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    • Insitut für Hygiene und Umweltmedizin, Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.  Axel  Kramer 
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    • Institut für Hygiene und Umweltmedizin Universitätsmedizin Greifswald
    • Ms.  Dr.  Kathleen  Dittmann 
    • Walter-Rathenau-Straße 49A
    • 17475  Greifswald
    • Germany
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    • Institut für Hygiene und Umweltmedizin Universitätsmedizin Greifswald
    • Ms.  Dr.  Kathleen  Dittmann 
    • Walter-Rathenau-Straße 49A
    • 17475  Greifswald
    • 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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    • Schülke & Mayr GmbH
    • Robert-Koch-Straße 2
    • 22851  Norderstedt
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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