Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03349268 |
| Other study ID # |
1R01HS024709-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2017 |
| Est. completion date |
April 15, 2020 |
Study information
| Verified date |
February 2022 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
