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

Healthcare Associated Infection Clinical Trial

— UVCLEAR-MDRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605499
• Other study ID #: IRB00063160
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Healthcare Associated Infection
• Multidrug Resistant Organisms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of Vancomycin Resistant Enterococcus	Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.	2 years
Primary	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	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
Secondary	Acquisition of Vancomycin Resistant Enterococcus (colonization)	Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.	2 years
Secondary	Acquisition of Clostridium difficile (infection)	Rates of Clostridium difficile infection will be compared between intervention and control periods.	2 years
Secondary	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
Secondary	Acquisition of bacteremia	Rates of hospital onset bacteremia will be compared between the intervention and control arms.	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Acquisition of Central line associated bloodstream infections	Rates of Central line associated bloodstream infections in intervention and control arms will be compared.	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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