Trial document




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  DRKS00005273

Trial Description

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Title

Epidemiology of multiresistant gram-negative bacteria (MRGN) in the context of hospital treatment at university hospital Jena – a prospective cohort study

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Trial Acronym

ESBL

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URL of the Trial

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Brief Summary in Lay Language

During the last 15 years a worrying increase of bacteria that develop resistance to many antibiotics is observed. With increasing development of resistance a confusing variety of terms emerged, resulting from e.g. the underlying mechanism, the place of primary isolation or the relevant pathogen species. To facilitate a uniform label for multidrug-resistant gram-negative rod bacteria was proposed by a Commission of experts: MRGN. The acronym stands for multidrug-resistant gram-negative bacteria. These MRGN occupy mostly the intestines and can be acquired both outside the hospital (approx. 5-10% of the population are populated with MRGN already) via food or during a hospital stay by smear infection. Infections with these pathogens are associated with higher morbidity and mortality. Actually, in Germany there are no studies that answer the question of how many patients at the hospital are already populated with MRGN bacteria and the risk of transmission of these pathogens to other patients in hospital. It is unknown whether patients who are colonised with MRGN lose these by repression of other bacteria of the resident microbiota in the course of time.
In the current study, the occurrence and the risk of transmission of MRGN bacteria are examined in a total of 2000 hospitalized patients. On admission to hospital and hospital discharge a rectal swab is examined on the occurrence with MRGN. If patients are colonised with MRGN bacteria at hospital discharge, a follow-up period of 6-month is planned. After 6 months, a rectal swab will be analysed again on the occurrence of MRGN.

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Brief Summary in Scientific Language

During the last 15 years a worrying increase of bacteria that develop resistance to many antibiotics is observed. Gram-negative rods can be subdivided into non-fermenting rods and Enterobacteriaceae. With increasing development of resistance a confusing variety of terms emerged, resulting from e.g. the underlying mechanism, the place of primary isolation or the relevant pathogen species. To facilitate a uniform label for multidrug-resistant gram-negative rod bacteria the term “MRGN” was proposed by KRINKO, a commission of experts, that comprises clinical relevance. In this context only resistance against antibiotics, that are used in critical ill patients are considered.
Actually, in Germany there are no studies that answer the question of how many patients at the hospital are already populated with MRGN bacteria and the risk of transmission of these pathogens to other patients in hospital. It is unknown whether patients who are colonised with MRGN lose these by repression of other bacteria of the resident microbiota in the course of time.
In the current study, the occurrence and the risk of transmission of MRGN bacteria are examined in a total of 2000 hospitalized patients. On admission to hospital and hospital discharge a rectal swab is examined on the occurrence with MRGN. If patients are colonised with MRGN bacteria at hospital discharge, a follow-up period of 6-month is planned. After 6 months, a rectal swab will be analysed again on the occurrence of MRGN.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005273
  •   2013/09/04
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  •   yes
  •   Approved
  •   3852-07/13, 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

  •   Within the study no specific disease pattern is investigated.
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Interventions/Observational Groups

  •   The occurrence and the risk of transmission of multiresistant gram-negative bacteria (MRGN) are examined in a total of 2000 hospitalized patients that fulfil the inclusion criteria. To it, on admission to hospital and hospital discharge a rectal swab is examined on the occurrence with MRGN. In case of MRGN colonisation at hospital discharge, a follow-up period of 6-month is planned.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- Rate of colonisation [n/1000 patients] with MRGN during hospital stay via quotient from number of patients that are colonised with a new MRGN bacteria at hospital discharge by number of total patients at hospital discharge

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Secondary Outcome

- Rate of nosocomial infection during hospital stay (Total, With MRGN (PFGE analysis), Selective for Full-Analysis-Setnegativ and Full-Analysis-SetMRGN)
- Acquirement of MRGN per 1000 antibiotic-days in hospital (per class of antibiotics, per substance, per antibiotic combination)
- Rate of colonisation with MRGN from that patients that are colonised with MRGN at hospital discharge (via quotient from patients that are colonised with MRGN at 6 month after hospital discharge by number of patients that are colonised at hospital discharge)
- clonality of all detected MRGN (PFGE-analysis)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/09/24
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- at least age of 18 years
- expected hospitalisation more than 48 hours
- admission from extern

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Exclusion Criteria

not any

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Addresses

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    • Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Prof. Dr. med.  Mathias  Pletz 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Prof. Dr. med.  Mathias  Pletz 
    • Erlanger Allee 101
    • 07745  Jena
    • Germany
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    • Universitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene
    • Mr.  Dr. med.  Stefan  Hagel 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/17
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Trial Publications, Results and other Documents

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