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

Three-armed Cluster-randomised decolonisation studie within the project "The effect of climate change on infections in Germany and studies on decolonisation" - CLIP-ID-AS2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010475

Enrollment

65250

Registered

2016-08-18

Start date

2017-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream infection Multidrug-resistant bacteria (MDRO) Sepsis U80-U85

Interventions

Group 1: 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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Austria, Germany

Contacts

Public ContactLuisa Denkel

Charité Universitätsmedizin Berlin Institut für Hygiene und Umweltmedizin

luisa.denkel@charite.de+49 30 450 570 043

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026