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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Acquisition of Vancomycin Resistant Enterococcus (clinical infection and colonization) [ Time Frame: 2 years ]
    Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection and colonization) 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. [ Time Frame: 2 years ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Acquisition of Vancomycin Resistant Enterococcus (clinical infection) [ Time Frame: 2 years ]
    Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.
  • Acquisition of Vancomycin Resistant Enterococcus (colonization) [ Time Frame: 2 years ]
    Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.
  • Acquisition of Clostridium difficile (infection) [ Time Frame: 2 years ]
    Rates of Clostridium difficile infection will be compared between intervention and control periods.
  • Acquisition of Clostridium difficile (colonization or infection) [ Time Frame: 2 years ]
    Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.
  • Acquisition of bacteremia [ Time Frame: 2 years ]
    Rates of hospital onset bacteremia will be compared between the intervention and control arms.
  • Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical) [ Time Frame: 2 years ]
    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.
  • Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization) [ Time Frame: 2 years ]
    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) [ Time Frame: 2 years ]
    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 [ Time Frame: 2 years ]
    Rates of Central line associated bloodstream infections in intervention and control arms will be compared.
  • Acquisition of multidrug resistant gram negative bacteria (colonization) [ Time Frame: 2 years ]
    Rates of multidrug resistant gram negative bacteria acquisition (colonization) will be compared between intervention and control periods.
  • Acquisition of multidrug resistant gram negative bacteria (colonization and clinical) [ Time Frame: 2 years ]
    Rates of multidrug resistant gram negative bacteria acquisition (colonization and clinical) 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. [ Time Frame: 2 years ]
    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. [ Time Frame: 2 years ]
    Patient satisfaction with environmental cleaning will be compared between intervention and control arms.


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: November 11, 2015
Date Started: November 2015
Date Completion: March 2018
Last Updated: November 12, 2015
Last Verified: November 2015