Trial document




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  DRKS00010475

Trial Description

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Title

Three-armed Cluster-randomised decolonisation studie within the project "The effect of climate change on infections in Germany and studies on decolonisation"

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Trial Acronym

CLIP-ID-AS2

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URL of the Trial

http://www.infectcontrol.de/de/clip-id.html

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Brief Summary in Lay Language

Bloodstream infections are very frequent complications of patients in intensive care units. The majority of intensive care unit-acquired bloodstream infections are caused by bacteria that belong to the natural flora of the skin. Disinfection of the skin can eliminate those bacteria. This study aims to investigate whether different infection prevention strategies including antiseptic washing of patients in intensive care units reduce the rates of bloodstream infections and multi-resistant bacteria in these units. Two antiseptic washing procedures will be tested for 12 months in 25 intensive care units per washing strategy. Further 25 intensive care units will continue to use non-antiseptic washing procedures. The efficacy of antiseptic washing procedures will be examined by the number of bloodstream infections and multidrug-resistant bacteria in the intensive care units participating in this study. Further, adverse effects of antiseptic body washing such as development of bacterial resistances against disinfectants or changes of the healthy skin flora will be tested.

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Brief Summary in Scientific Language

This cluster-randomised decolonisation study aims to examine the efficacy of infection control strategies with antiseptic washing procedures to reduce nosocomial primary bloodstream infections (BSI) and multi-drug resistant organisms (MDRO) in German intensive care units (ICUs). Therefore, 75 ICUs will be included. These ICUs are participants of the German national surveillance system for nosocomial infections in ICUs (ICU-KISS) and keep record of all BSIs on their wards. ICUs eligible for participation will be randomised in one of three groups: 1st intervention group: Teaching of staff in infection control and use of Chlorhexidindi-gluconate (CHG) cloths, washing of all patients with CHG cloths. 2nd Intervention Group: teaching of staff in infection control and use of Octenidine-wash mitts, washing of all patients with Octenidine-wash mitts. Control Group: Teaching of staff in infection control and appropriate washing, washing of patients with water and soap. Use of CHG wash cloths or Octenidine-wash mitts after the first intervention period (2018) for 12 months to test effectiveness .

The potential preventive effect of the antiseptic washing procedures will be analysed by comparing the numbers of unit-based BSI and MDRO in the intervention groups and the control group. Climate factors will be considered in the analysis. Further, also adverse effects such as changes of the skin microbiome and development of bacterial resistances against CHG and octenidine will be examined.

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Organizational Data

  •   DRKS00010475
  •   2016/08/18
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  •   yes
  •   Approved
  •   EA1/093/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Bloodstream infection
  •   Multidrug-resistant bacteria (MDRO)
  •   U80-U85 -  [---]*
  •   Sepsis
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Interventions/Observational Groups

  •   Teaching of staff in infection control and use of CHG-wash cloths, washing of all patients with CHG wash cloths.
    CHG Sage 20 mg/ml impragnated wash clothes by Sage Products is registered in Germany as a pharmaceutical product (No. 88162.00.00). CHG wash cloths will be provided by Sage Products.
  •   Teaching of staff in infection control and use of Octenidine-wash mitts, washing of all patients with Octenidine-wash mitts. Octenisan md wash mitts (Schülke&Mayr) are impregnated one-time-use wash mitts for decontamination of body and hair. The active component is Octenidine dihydrochloride, a kationic surface-active substance.
    Octenidine-wash mitts by Schülke & Mayr is currently registered in Germany as a cosmetic product. Application process for registration as a medical product is ongoing (August 2016). Octenidine-wash mitts will be provided by Schülke & Mayr.
  •   Teaching of staff in infection control and appropriate washing of patients with water and soap. Use of CHG wash cloths or Octenidine-wash mitts after the first intervention period (January 2018) for 12 months. Antiseptic products will be provided by CLIP-ID.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Primary endpoint is the incidence rate of nosocomial blood stream infections (BSI). The number of BSI is documented prospectively in ICU-KISS by specially trained surveillance personnel. The surveillance is done independent from this study for the purpose of infection control and quality management. Study arms with antiseptic washing are compared with the control arm without antiseptic washing) for the 12 months of intervention.

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Secondary Outcome

Secondary endpoint is the incidence rate of multidrug-resistant organisms (MDRO) that is documented in ICU-KISS by specially trained surveillance personnel. The number of patients colonised or infected with MDRO (e.g. methicillin-resistant Staphylococcus aureus - MRSA, multiresistent Gram-negative bacteria - MRGN and / or Vancomycin-resistant enterococci - VRE) and / or Clostridium difficile - associated diarrhoea (CDAD) per unit is documented prospectively. The surveillance is done independent from this study for the purpose of infection control and quality management.

Further secondary endpoints are examination of resistance to CHG and octenidine and the changes of the skin microbiome before and after the intervention.
10 clinical isolates per unit are collected from patients with at least 5 days length of stay on the unit before and after the Intervention, respectively. Resistance tests are performed by minimal inhibitory concentration (MIC) tests (comparison of study arms with antiseptic washing and control arm without antiseptic washing, before-after).

The skin microbiome is examined by 16S-rRNA-sequencing in one unit per study arm (with 30 patients each). Composition, diversity and species of skin microbiome of ICU-patients before and after the intervention (comparison of study arms with antiseptic washing and control arm without antiseptic washing, before-after) are examined. Differences of the skin microbiome are identified by Shannon-index.

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2017/02/01
  •   65250
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

This cluster-randomised decolonisation study is unit-based.
Inclusion criteria for ICUs:
- Participation in ICU-KISS, incidence rate of nosocomial BSI above a certain threshold (dependent on type of ICU) of BSI in ICU-KISS
- interdisciplinary, medical, surgical ICU

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Exclusion Criteria

Exclusion criteria for ICUs:

- current or planned (until 2017) antiseptic washing procedures (e.g. with Octenidin wash mitts, CHG wash clothes) of all patients in ICU
- incidence rate of nosocomial BSI below the defined threshold in ICU-KISS
- all ICUs other than interdisciplinary, medical or surgical

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Addresses

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    • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • HautmikrobiomUniversitätsklinikum Jena, ZIK Septomics, Forschergruppe Host Septomics,
    • Ms.  Prof. Dr.   Hortense  Slevogt 
    • Albert-Einstein-Str. 10,
    • 07745   Jena
    • Germany
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    • Research & Development Schülke&Mayr GmbH
    • Mr.  Dr.  Jörg  Siebert 
    • Robert-Koch-Str. 2
    • 22851  Norderstedt
    • Germany
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    • Charité Universitätsmedizin Berlin Institut für Hygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.   Christine  Geffers 
    • Hindenburgdamm 27
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Institut für Hygiene und Umweltmedizin
    • Ms.  Dr. rer. nat.  Luisa  Denkel 
    • Hindenburgdamm 27
    • 12203  Berlin
    • 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
  •   2019/04/30
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Trial Publications, Results and other Documents

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