Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection

The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning).

The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii.

At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection; Healthcare Associated Infection; Infection Due to Multidrug Resistant Bacteria
• Intervention / Treatment: Device: Pulsed xenon ultraviolet (PX-UV) Device; Device: Sham Device

Detailed Description

In 2011, 721,800 healthcare-associated infections (HAIs) were reported in the United States. The hospital environment has been increasingly recognized as an important determinant of HAI acquisition and prevention of HAIs has become a top priority for the U.S. Department of Health and Human Services (HHS). Terminal cleaning of a patient room is recognized as a critically important process to help prevent HAIs and involves extensive cleaning and disinfection of the room after a patient has been discharged from the room and before the subsequent patient has been admitted to the room. Pulsed xenon ultraviolet light (PX-UV) has been shown to be effective in killing a variety of pathogens including endospores of Clostridium difficile. PX-UV works quickly - the entire cycle time for use in a hospital room is 15 minutes. To date, the clinical impact of adding PX-UV to terminal cleaning has not been demonstrated in clinical trials with sham controls or in a crossover design. The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii. The objective of this application is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning). At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.

• Study Type: Interventional
• Enrollment (Actual): 25732
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48205
      • Detroit Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients admitted to the study units will be eligible
• Only patients who remain in the hospital for four calendar days or longer will be eligible for evaluation of eiHAI outcomes (the day of admission counts as calendar day one).
• Patients who do not develop an eiHAI at the time of unit discharge will be eligible for eiHAI outcomes for up to calendar 3 days following unit discharge.

Exclusion Criteria:

- All patients not cared for on study units

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV; Pulsed xenon ultraviolet light (PX-UV) Device to be used to disinfect rooms following post-discharge terminal cleaning	Device: Pulsed xenon ultraviolet (PX-UV) Device; Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.; Device: Sham Device; Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.
Sham Comparator: Sham Device - Non Emitting Germicidal UV; Sham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted.	Device: Pulsed xenon ultraviolet (PX-UV) Device; Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.; Device: Sham Device; Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning	PX-UV Device was used following each discharge on study units, with intervention devices emitting germicidal UV on 50% of the units and sham devices not emitting germicidal UV on 50% of the units.	24 months (Two 12 month phases)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Wayne State University; Henry Ford Health System; Agency for Healthcare Research and Quality (AHRQ); Detroit Medical Center; TEMPVA Research Group, Inc.; Xenex Disinfection Services LLC
• Investigators: Principal Investigator: Keith S. Kaye, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Iatrogenic Disease; Infections; Communicable Diseases; Clostridium Infections; Cross Infection; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: 1R01HS024709-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes