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Procedure

Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV for Clostridium Difficile Infection

N/A
Waitlist Available
Led By Keith S. Kaye, MD, MPH
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months (two 12 month phases)
Awards & highlights

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.

Eligible Conditions
  • Clostridium Difficile Infection
  • Healthcare-Associated Infections
  • Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months (two 12 month phases)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months (two 12 month phases) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UVActive Control2 Interventions
Pulsed xenon ultraviolet light (PX-UV) Device to be used to disinfect rooms following post-discharge terminal cleaning
Group II: Sham Device - Non Emitting Germicidal UVPlacebo Group2 Interventions
Sham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted.

Find a Location

Who is running the clinical trial?

TEMPVA Research Group, Inc.OTHER
1 Previous Clinical Trials
300 Total Patients Enrolled
Wayne State UniversityOTHER
312 Previous Clinical Trials
83,319 Total Patients Enrolled
Detroit Medical CenterOTHER
3 Previous Clinical Trials
1,915 Total Patients Enrolled
~3151 spots leftby Sep 2025