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
About this trial
This is an interventional prevention trial for Healthcare Associated Infection
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
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
NCT ID
NCT02605499
First Posted
November 11, 2015
Last Updated
September 17, 2018
Sponsor
Johns Hopkins University
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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