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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 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 25,732 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03349268
The ClinicalTrials.gov registry entry for NCT03349268 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25,732 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.
NCT03349268 reports 0 study locations.
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.
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