An interventional study of Pulsed xenon ultraviolet (PX-UV) Device and Sham Device in Healthcare Associated Infection, Clostridium Difficile Infection and Infection Due to Multidrug Resistant Bacteria, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
Among 60 studies in Cross Infection with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Cross Infection · United States.
Among the 60 studies in Cross Infection with a site in United States, this one is the 3rd largest by enrollment of the 40 interventional ones that give a count, is one of 2 that started in 2017, is one of 20 with no phase, and was the 39th registered.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
Browse Cross Infection studies →5 of the 60 studies in Cross Infection with a site in United States are open now. Recruiting first, the newest first:
Swedish Medical Center · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18+
University of North Carolina, Chapel Hill · Sites in United States
Ages 1 mo–99 yrs
Oregon Health and Science University · Sites in United States
Ages 18–99
National Institutes of Health Clinical Center (CC) · Sites in United States
Ages 2–120
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Cross Infection studies recruiting now, 22 (81%) set no upper age limit and 3 (11%) stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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60 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 5 · Phase 4 4
First in 2001; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25,732 is above the median of 185 across 169 interventional studies indexed under Cross Infection.
Median enrollment 167 across the 40 interventional studies, 525 across the 20 observational. Of the 51 that completed or were terminated, 22 (43%) have results posted.
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9 of 60 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 4 studies filed under Cross Infection — fewer than ten, so there is no comparison to draw.
1 of the studies in Cross Infection with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06378359University of MinnesotaEffectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients | 2026-12-31 |
Among the 60 studies in Cross Infection with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pulsed xenon ultraviolet light (PX-UV) Device to be used to disinfect rooms following post-discharge terminal cleaning
Device: Pulsed xenon ultraviolet (PX-UV) Device · Device: Sham Device
Sham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted.
Device: Pulsed xenon ultraviolet (PX-UV) Device · Device: Sham Device
Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.
Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds. Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2.
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning
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.
Time frame: 24 months (Two 12 month phases)
| Milestone | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | Patients Cared for on Both PX-UV and Sham Units |
|---|---|---|---|
| Started | 9117 | 10296 | 6319 |
| Completed | 9117 | 10296 | 6319 |
| Not completed | 0 | 0 | 0 |
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.
| eiHAIs | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units |
|---|---|---|
| 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | — | — | — |
| Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | — | — | — |
| Patients Cared for on Both PX-UV and Sham Units | — | — | — |
| Age, Continuous(years) | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | Patients Cared for on Both PX-UV and Sham Units | Total |
|---|---|---|---|---|
| Mean | 57.4 ± 18.23 | 57.46 ± 18.41 | 61.50 ± 16.51 | 58.43 ± 17.98 |
| Sex/Gender, Customized(Participants) | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | Patients Cared for on Both PX-UV and Sham Units | Total |
|---|---|---|---|---|
| Female | 4253 | 4962 | 3018 | 12233 |
| Male | 4858 | 5333 | 3291 | 13482 |
| Unknown | 6 | 1 | 10 | 17 |
| Race/Ethnicity, Customized(Participants) | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | Patients Cared for on Both PX-UV and Sham Units | Total |
|---|---|---|---|---|
| American Indian/Alaska Native | 32 | 34 | 20 | 86 |
| Asian/Pacific Islander | 31 | 22 | 13 | 66 |
| Black or African American | 7142 | 8085 | 5212 | 20439 |
| White | 933 | 1025 | 419 | 2377 |
| Unknown/Not Reported/Other | 979 | 1130 | 655 | 2764 |
| Region of Enrollment(participants) | Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units | Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units | Patients Cared for on Both PX-UV and Sham Units | Total |
|---|---|---|---|---|
| United States | 9117 | 10296 | 6319 | 25732 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Jan 2020, 30 months.
Results were first posted in Mar 2022, 2 years 1 month after primary completion. A results delay was requested in Dec 2020.
Of 57 non-industry interventional studies with no phase under Cross Infection, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 30 months is above that.
Counting every sponsor, half of 59 studies reached it within 16 months; a quarter within 6 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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