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NCT03349268 · ClinicalTrials.gov registry record · NA
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 25,732
- Enrollment target
NCT03349268: Completed NA study, sponsored by University of Michigan.
NCT03349268 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 25,732 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1734% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03349268, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 25,732 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Sham Device
- DEVICE Pulsed xenon ultraviolet (PX-UV) Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,732 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2020-04-15 |
| Phase | NA |
What the finished NCT03349268 record still lists
NCT03349268 is an interventional study that assigns participants to a tested intervention. Its 25,732 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1734% higher).
The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.
NCT03349268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03349268 about?
NCT03349268 is a clinical study titled "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. Outcom...
What is the current status of trial NCT03349268?
This trial is currently completed. It is a NA study. The enrollment target is 25,732 participants. The study started on 2017-07-07. Estimated completion is 2020-04-15.
What interventions are being tested in trial NCT03349268?
The interventions under investigation include: Sham Device (DEVICE), Pulsed xenon ultraviolet (PX-UV) Device (DEVICE).
Who is sponsoring clinical trial NCT03349268?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03349268's enrollment target sits among peer trials
25,732 9th of 2000 higher than 1,992 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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