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

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.

Study Overview

• Status: Completed
• Conditions: Healthcare Associated Infection; Multidrug Resistant Organisms
• Intervention / Treatment: Other: UV-C light disinfection

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UV-C light disinfection; During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.	Other: UV-C light disinfection; UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.
No Intervention: Control; During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of Vancomycin Resistant Enterococcus	Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.	2 years
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of Vancomycin Resistant Enterococcus (clinical infection)	Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.	2 years
Acquisition of Vancomycin Resistant Enterococcus (colonization)	Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.	2 years
Acquisition of Clostridium difficile (infection)	Rates of Clostridium difficile infection will be compared between intervention and control periods.	2 years
Acquisition of Clostridium difficile (colonization or infection)	Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.	2 years
Acquisition of bacteremia	Rates of hospital onset bacteremia will be compared between the intervention and control arms.	2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)	Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.	2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)	Rates of Methicillin Resistant Staphylococcus Aureus acquisition (colonization) will be compared between intervention and control periods.	2 years
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.	2 years
Acquisition of Central line associated bloodstream infections	Rates of Central line associated bloodstream infections in intervention and control arms will be compared.	2 years
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.	2 years
Acquisition of multidrug resistant gram negative bacteria	Rates of multidrug resistant gram negative bacteria acquisition will be compared between intervention and control periods.	2 years
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.	2 years
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.	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Lisa Maragakis, MD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: IRB00063160