Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection

NCT03349268 | Completed Results FDA Device

• 1 other identifier: 1R01HS024709-01
• Study Type: interventional
• Target: 25,732
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthcare Associated Infection; Clostridium Difficile Infection; Infection Due to Multidrug Resistant Bacteria

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV

ACTIVE COMPARATOR

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; Device: Sham Device

Sham Device - Non Emitting Germicidal UV

SHAM COMPARATOR

Sham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted.

Device: Pulsed xenon ultraviolet (PX-UV) Device; Device: Sham Device

Interventions

Pulsed xenon ultraviolet (PX-UV) Device 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.

Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV; Sham Device - Non Emitting Germicidal UV

Sham Device 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.

Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV; Sham Device - Non Emitting Germicidal UV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- All patients not cared for on study units

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Xenex Disinfection Services LLC: collaborator
• Detroit Medical Center: collaborator
• Henry Ford Health System: collaborator
• TEMPVA Research Group, Inc.: collaborator
• Wayne State University: collaborator

Study Sites (1)

Detroit Medical Center

Detroit, Michigan, 48205, United States

Location

Related Publications (1)

• Dhar S, Jinadatha C, Kilgore PE, Henig O, Divine GW, Todter EN, Coppin JD, Carter MJ, Chopra T, Egbert S, Carling PC, Kaye KS. Lowering the Acquisition of Multidrug-Resistant Organisms (MDROs) With Pulsed-xenon (LAMP) Study: A Cluster-Randomized, Controlled, Double-Blinded, Interventional Crossover Trial. Clin Infect Dis. 2024 Oct 15;79(4):1024-1030. doi: 10.1093/cid/ciae240.

  PMID: 38743564 DERIVED

MeSH Terms

Conditions

Cross Infection; Clostridium Infections

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Keith Kaye
• Organization: University of Michigan

kk1116@rwjms.rutgers.edu

732 235-9312

Study Officials

• Keith S. Kaye, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All healthcare personnel (including device operators and environmental services staff) will be blinded to the intervention/sham status of the devices. In addition, the study personel including the PI and individuals performing data analysis, will be blinded to the intervention/sham status of the devices. The device status will be written on a piece of paper by the manufacturer with the serial numbers of each device indicated, sealed in an envelope and kept in a secure location by the study statistician for later retrieval when trial data analysis has been completed.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-armed crossover with an initial intervention period of 12 months, followed by a 6 month washout period and a second intervention period of 12 months. The 6 month washout period will be necessary because of the long-term survivability of eiHAIs, such as C. difficile, on environmental services.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 21, 2017
• Study Start: July 7, 2017
• Primary Completion: January 31, 2020
• Study Completion: April 15, 2020
• Last Updated: March 14, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-02

Locations

US (1)