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N/A N=25,732 Randomized Quadruple-blind Prevention

Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection

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

Enrolled (actual)
25,732
Serious AEs
Results posted
Mar 2022
Primary outcome: Primary: Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning — 303; 298 eiHAIs — p=0.23

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Pulsed xenon ultraviolet (PX-UV) Device (Device); Sham Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Jan 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning
303; 298 0.23

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03349268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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