Healthcare Associated InfectionNCT03349268
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
A study testing Pulsed xenon ultraviolet (PX-UV) Device in people with Healthcare Associated Infection and Clostridium Difficile Infection, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infection, Clostridium Difficile Infection, Infection Due to Multidrug Resistant Bacteria
- What is being tested?
- Pulsed xenon ultraviolet (PX-UV) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,732 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All patients not cared for on study units
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Healthcare Associated Infection, Clostridium Difficile Infection, Infection Due to Multidrug Resistant Bacteria
- Being tested
- Pulsed xenon ultraviolet (PX-UV) Device, Sham Device
- Medical subject headings
- Cross Infection, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed xenon ultraviolet (PX-UV) DeviceDevice
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.
Sham DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV | Active comparator | Pulsed xenon ultraviolet light (PX-UV) Device to be used to disinfect rooms following post-discharge terminal cleaning Receives: Device: Pulsed xenon ultraviolet (PX-UV) Device; Device: Sham Device |
| Sham Device - Non Emitting Germicidal UV | Sham comparator | Sham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted. Receives: Device: Pulsed xenon ultraviolet (PX-UV) Device; Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months (Two 12 month phases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start7 Jul 2017
- Primary completion31 Jan 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-armed crossover with an initial intervention period of 12 months, followed by a 6 month washout period and a second intervention period of 12 months. The 6 month washout period will be necessary because of the long-term survivability of eiHAIs, such as C. difficile, on environmental services.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,732 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Xenex Disinfection Services LLC, Detroit Medical Center, Henry Ford Health System, TEMPVA Research Group, Inc., Wayne State University
- Responsible party
- Principal investigator, keith kaye, University of Michigan
- Investigators
- Keith S. Kaye, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349268
- Sponsor's protocol ID
- 1R01HS024709-01
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2017
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Dhar S, Jinadatha C, Kilgore PE, Henig O, Divine GW, Todter EN, Coppin JD, Carter MJ, Chopra T, Egbert S, Carling PC, Kaye KS. Lowering the Acquisition of Multidrug-Resistant Organisms (MDROs) With Pulsed-xenon (LAMP) Study: A Cluster-Randomized, Controlled, Double-Blinded, Interventional Crossover Trial. Clin Infect Dis. 2024 Oct 15;79(4):1024-1030. doi: 10.1093/cid/ciae240.
PubMed 38743564
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
- ClinicalTrials.gov ID
- NCT03349268
- Acronym / sponsor ID
- 1R01HS024709-01
- Conditions
- Healthcare Associated Infection, Clostridium Difficile Infection, Infection Due to Multidrug Resistant Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,732 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Xenex Disinfection Services LLC, Detroit Medical Center, Henry Ford Health System, TEMPVA Research Group, Inc., Wayne State University
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-armed crossover with an initial intervention period of 12 months, followed by a 6 month washout period and a second intervention period of 12 months. The 6 month washout period will be necessary because of the long-term survivability of eiHAIs, such as C. difficile, on environmental services.
| Arm | Type | Receives |
|---|---|---|
| Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV | Active comparator | Device: Pulsed xenon ultraviolet (PX-UV) Device, Device: Sham DevicePulsed xenon ultraviolet light (PX-UV) Device to be used to disinfect rooms following post-discharge terminal cleaning |
| Sham Device - Non Emitting Germicidal UV | Sham comparator | Device: Pulsed xenon ultraviolet (PX-UV) Device, Device: Sham DeviceSham Device to be run in rooms following post-discharge terminal cleaning. No Germicidal UV is emitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- All patients not cared for on study units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed xenon ultraviolet (PX-UV) DeviceTwo 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. | Device | Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV, Sham Device - Non Emitting Germicidal UV |
| Sham DeviceTwo 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. | Device | Pulsed xenon ultraviolet light (PX-UV) Device Emitting Germicidal UV, Sham Device - Non Emitting Germicidal UV |
Primary outcome
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning
Time frame: 24 months (Two 12 month phases)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38743564Dhar S, Jinadatha C, Kilgore PE, Henig O, Divine GW, Todter EN, Coppin JD, Carter MJ, Chopra T, Egbert S, Carling PC, Kaye KS. Lowering the Acquisition of Multidrug-Resistant Organisms (MDROs) With Pulsed-xenon (LAMP) Study: A Cluster-Randomized, Controlled, Double-Blinded, Interventional Crossover Trial. Clin Infect Dis. 2024 Oct 15;79(4):1024-1030. doi: 10.1093/cid/ciae240.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith S. Kaye, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed xenon ultraviolet (PX-UV) Device in people with Healthcare Associated Infection and Clostridium Difficile Infection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning (time frame: 24 months (Two 12 month phases)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03349268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.