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4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings (Duclorexint)

Primary Purpose

Hospital Infection

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
4% chlorhexidine gluconate soap-like solution
standard soap
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hospital Infection focused on measuring 4% chlorhexidine gluconate, infection control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
  • ICU/PC-ICU stay for at least 1 night

Exclusion Criteria:

  • known allergy to chlorhexidine
  • burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Arm

    Control Arm

    Arm Description

    daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing

    daily bathing with standard soap

    Outcomes

    Primary Outcome Measures

    hospital acquired infections incidence
    cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)

    Secondary Outcome Measures

    Ventilator-associated pnemonias (VAP) incidence
    VAP incidence
    Bloodstream infections (BSI) incidence
    BSI incidence
    central-line associated BSI (CLABSI) incidence
    CLABSI incidence
    urinary tract infections (UTI) incidence
    UTI incidence
    catheter associated UTI (CAUTI) incidence
    CAUTI incidence
    4% CHG daily bathing safety
    overall mortality in the treatment and control arm
    4% CHG daily bathing-related adverse events
    4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events
    time till infection
    time between admission to ICU/PC-ICU and infection occurrence

    Full Information

    First Posted
    August 13, 2018
    Last Updated
    August 17, 2018
    Sponsor
    University Of Perugia
    Collaborators
    Fondazione Toscana Gabriele Monasterio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03639363
    Brief Title
    4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings
    Acronym
    Duclorexint
    Official Title
    Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 10, 2015 (Actual)
    Primary Completion Date
    April 28, 2016 (Actual)
    Study Completion Date
    May 2, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Of Perugia
    Collaborators
    Fondazione Toscana Gabriele Monasterio

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hospital Infection
    Keywords
    4% chlorhexidine gluconate, infection control

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    449 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing
    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm Description
    daily bathing with standard soap
    Intervention Type
    Drug
    Intervention Name(s)
    4% chlorhexidine gluconate soap-like solution
    Intervention Description
    humidify the whole body surface with the exception of the face using water-impregnated washcloths use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG wait for at least 30 seconds rinse using water-impregnated washcloths
    Intervention Type
    Other
    Intervention Name(s)
    standard soap
    Intervention Description
    humidify the whole body surface with the exception of the face using water-impregnated washcloths use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face wait for at least 30 seconds rinse using water-impregnated washcloths
    Primary Outcome Measure Information:
    Title
    hospital acquired infections incidence
    Description
    cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Secondary Outcome Measure Information:
    Title
    Ventilator-associated pnemonias (VAP) incidence
    Description
    VAP incidence
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Title
    Bloodstream infections (BSI) incidence
    Description
    BSI incidence
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Title
    central-line associated BSI (CLABSI) incidence
    Description
    CLABSI incidence
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Title
    urinary tract infections (UTI) incidence
    Description
    UTI incidence
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Title
    catheter associated UTI (CAUTI) incidence
    Description
    CAUTI incidence
    Time Frame
    infections occured 48 hours after admission to ICU/PC-ICU
    Title
    4% CHG daily bathing safety
    Description
    overall mortality in the treatment and control arm
    Time Frame
    at discharge, approximately up to 10 days
    Title
    4% CHG daily bathing-related adverse events
    Description
    4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events
    Time Frame
    at discharge, approximately up to 10 days
    Title
    time till infection
    Description
    time between admission to ICU/PC-ICU and infection occurrence
    Time Frame
    at discharge, approximately up to 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU) ICU/PC-ICU stay for at least 1 night Exclusion Criteria: known allergy to chlorhexidine burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    franco baldelli, Professor
    Organizational Affiliation
    Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30267930
    Citation
    Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26.
    Results Reference
    derived

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    4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings

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