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Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO) (UVCLEAR-MDRO)

Primary Purpose

Healthcare Associated Infection, Multidrug Resistant Organisms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UV-C light disinfection
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthcare Associated Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Patient rooms in pre-selected hospital units within Johns Hopkins Hospital

Exclusion Criteria:

  • None, intervention is at level of the hospital unit, not the patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    UV-C light disinfection

    Control

    Arm Description

    During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

    During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection.

    Outcomes

    Primary Outcome Measures

    Acquisition of Vancomycin Resistant Enterococcus
    Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.
    Acquisition of a composite rate of healthcare-associated bacteria: Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, Clostridium difficile, and central line associated bloodstream infections.
    Rates of Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, multidrug resistant gram negative bacteria, Clostridium difficile, and central line associated bloodstream infections will be compared between intervention and control periods.

    Secondary Outcome Measures

    Acquisition of Vancomycin Resistant Enterococcus (clinical infection)
    Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.
    Acquisition of Vancomycin Resistant Enterococcus (colonization)
    Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.
    Acquisition of Clostridium difficile (infection)
    Rates of Clostridium difficile infection will be compared between intervention and control periods.
    Acquisition of Clostridium difficile (colonization or infection)
    Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.
    Acquisition of bacteremia
    Rates of hospital onset bacteremia will be compared between the intervention and control arms.
    Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.
    Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (colonization) will be compared between intervention and control periods.
    Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical or colonization) will be compared between intervention and control periods.
    Acquisition of Central line associated bloodstream infections
    Rates of Central line associated bloodstream infections in intervention and control arms will be compared.
    Acquisition of multidrug resistant gram negative bacteria (colonization)
    Rates of multidrug resistant gram negative bacteria acquisition (colonization) will be compared between intervention and control periods.
    Acquisition of multidrug resistant gram negative bacteria
    Rates of multidrug resistant gram negative bacteria acquisition will be compared between intervention and control periods.
    Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
    Patient satisfaction with overall hospital stay will be compared between intervention and control arms.
    Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
    Patient satisfaction with environmental cleaning will be compared between intervention and control arms.

    Full Information

    First Posted
    November 11, 2015
    Last Updated
    September 17, 2018
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02605499
    Brief Title
    Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
    Acronym
    UVCLEAR-MDRO
    Official Title
    Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (Actual)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria. Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
    Detailed Description
    Effective cleaning of the patient environment (the patient room during hospital stay) is subject to human factors and unfortunately is often inconsistent or inadequate. Patient rooms that have residual bacteria after routine environmental cleaning can act as reservoirs for multidrug-resistant organisms (MDROs) and contribute to the spread of MDROs from patient to patient. In the setting of an increased focus on Healthcare-associated Infections such as Clostridium difficile (C. difficile) and multidrug-resistant Gram negative and Gram positive organisms such as carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphlococcus aureus (MRSA), Ultra-Violet C (UV-C) light has been shown to be a safe, effective way to decrease the burden of MDROs in patient rooms. However, studies examining the effectiveness of UV-C light when used post daily and discharge patient room cleaning are lacking. This study is a cluster, randomized, two-period cross over trial to investigate the relationship between environmental decontamination with UV-C light and transmission of VRE and other healthcare-associated bacteria. It investigates the hypothesis that UV-C in addition to daily cleaning leads to decreased patient acquisition of healthcare-associated bacteria. This study is important to further advance hospital-based infection prevention knowledge of the impact of UV-C light for environmental cleaning. Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthcare Associated Infection, Multidrug Resistant Organisms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    UV-C light disinfection
    Arm Type
    Experimental
    Arm Description
    During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection.
    Intervention Type
    Other
    Intervention Name(s)
    UV-C light disinfection
    Intervention Description
    UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.
    Primary Outcome Measure Information:
    Title
    Acquisition of Vancomycin Resistant Enterococcus
    Description
    Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of a composite rate of healthcare-associated bacteria: Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, Clostridium difficile, and central line associated bloodstream infections.
    Description
    Rates of Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, multidrug resistant gram negative bacteria, Clostridium difficile, and central line associated bloodstream infections will be compared between intervention and control periods.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Acquisition of Vancomycin Resistant Enterococcus (clinical infection)
    Description
    Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Vancomycin Resistant Enterococcus (colonization)
    Description
    Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Clostridium difficile (infection)
    Description
    Rates of Clostridium difficile infection will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Clostridium difficile (colonization or infection)
    Description
    Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.
    Time Frame
    2 years
    Title
    Acquisition of bacteremia
    Description
    Rates of hospital onset bacteremia will be compared between the intervention and control arms.
    Time Frame
    2 years
    Title
    Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)
    Description
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)
    Description
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (colonization) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)
    Description
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical or colonization) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of Central line associated bloodstream infections
    Description
    Rates of Central line associated bloodstream infections in intervention and control arms will be compared.
    Time Frame
    2 years
    Title
    Acquisition of multidrug resistant gram negative bacteria (colonization)
    Description
    Rates of multidrug resistant gram negative bacteria acquisition (colonization) will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Acquisition of multidrug resistant gram negative bacteria
    Description
    Rates of multidrug resistant gram negative bacteria acquisition will be compared between intervention and control periods.
    Time Frame
    2 years
    Title
    Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
    Description
    Patient satisfaction with overall hospital stay will be compared between intervention and control arms.
    Time Frame
    2 years
    Title
    Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
    Description
    Patient satisfaction with environmental cleaning will be compared between intervention and control arms.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient rooms in pre-selected hospital units within Johns Hopkins Hospital Exclusion Criteria: None, intervention is at level of the hospital unit, not the patient
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Maragakis, MD, MPH
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34636853
    Citation
    Rock C, Hsu YJ, Curless MS, Carroll KC, Ross Howard T, Carson KA, Cummings S, Anderson M, Milstone AM, Maragakis LL. Ultraviolet-C Light Evaluation as Adjunct Disinfection to Remove Multidrug-Resistant Organisms. Clin Infect Dis. 2022 Aug 24;75(1):35-40. doi: 10.1093/cid/ciab896.
    Results Reference
    derived

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    Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)

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