Clinical trial NCT02605499: Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
Official title: Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Associated Infection
Multidrug Resistant Organisms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 83
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Acquisition of Vancomycin Resistant Enterococcus
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Acquisition of Vancomycin Resistant Enterococcus (clinical infection)
timeFrame: 2 years
measure: Acquisition of Vancomycin Resistant Enterococcus (colonization)
timeFrame: 2 years
measure: Acquisition of Clostridium difficile (infection)
timeFrame: 2 years
measure: Acquisition of Clostridium difficile (colonization or infection)
timeFrame: 2 years
measure: Acquisition of bacteremia
timeFrame: 2 years
measure: Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)
timeFrame: 2 years
measure: Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)
timeFrame: 2 years
measure: Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)
timeFrame: 2 years
measure: Acquisition of Central line associated bloodstream infections
timeFrame: 2 years
measure: Acquisition of multidrug resistant gram negative bacteria (colonization)
timeFrame: 2 years
measure: Acquisition of multidrug resistant gram negative bacteria
timeFrame: 2 years
measure: Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
timeFrame: 2 years
measure: Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Lisa Maragakis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.