Clostridium Difficile Infection, Healthcare Associated Infection, Infection Due to Multidrug Resistant Bacteria
Conditions
Brief 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.
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.
Interventions
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.
Sponsors
Study design
Masking description
All healthcare personnel (including device operators and environmental services staff) will be blinded to the intervention/sham status of the devices. In addition, the study personel including the PI and individuals performing data analysis, will be blinded to the intervention/sham status of the devices. The device status will be written on a piece of paper by the manufacturer with the serial numbers of each device indicated, sealed in an envelope and kept in a secure location by the study statistician for later retrieval when trial data analysis has been completed.
Intervention 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.
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
\- All patients not cared for on study units
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning | 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. |
Countries
United States
Participant flow
Pre-assignment details
PX-UV Disinfection, real or sham, occurred in rooms after each patient discharge when the room is unoccupied, so there is no direct risk to the patient from PX-UV disinfection treatments. Patients' medical treatment was not impacted in any way, and there was no additional testing in the study. The IRB waived consent. There is no numerical difference between started and complete, because definitionally, any patient in an included room was counted and their data was used to determine eiHAIs.
Participants by arm
| Arm | Count |
|---|---|
| Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2. | 9,117 |
| Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were 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) were assigned randomly to the units in Phase 1 and then switched in Phase 2. | 10,296 |
| Patients Cared for on Both PX-UV and Sham Units Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable. | 6,319 |
| Total | 25,732 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 18.23 | 57.46 years STANDARD_DEVIATION 18.41 | 61.50 years STANDARD_DEVIATION 16.51 | 58.43 years STANDARD_DEVIATION 17.98 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 32 Participants | 34 Participants | 20 Participants | 86 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 31 Participants | 22 Participants | 13 Participants | 66 Participants |
| Race/Ethnicity, Customized Black or African American | 7142 Participants | 8085 Participants | 5212 Participants | 20439 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported/Other | 979 Participants | 1130 Participants | 655 Participants | 2764 Participants |
| Race/Ethnicity, Customized White | 933 Participants | 1025 Participants | 419 Participants | 2377 Participants |
| Region of Enrollment United States | 9117 participants | 10296 participants | 6319 participants | 25732 participants |
| Sex/Gender, Customized Female | 4253 Participants | 4962 Participants | 3018 Participants | 12233 Participants |
| Sex/Gender, Customized Male | 4858 Participants | 5333 Participants | 3291 Participants | 13482 Participants |
| Sex/Gender, Customized Unknown | 6 Participants | 1 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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)
Population: It was not part of the original intention of the study to evaluate patients who were in both study environments.~Because these patients were exposed to both study environments, their outcomes could not be attributed to either study intervention. Therefore the de facto third arm which accounts for them is not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device 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 eiHAIs |
| 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 | 298 eiHAIs |