Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.
Condition | Intervention |
---|---|
Multidrug Resistant Organisms Healthcare Associated Infections |
Other: Quaternary ammonium Other: Bleach Other: Quaternary ammonium and UV-C light Other: Bleach and UV-C light |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes |
- Clinical incidence rate of four target organisms among patients admitted to a study room [ Time Frame: 90 days ] [ Designated as safety issue: No ]Patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. Cultures for vegetative bacteria (MRSA, VRE, Acinetobacter) will be included if obtained within 90 days of discharge from a seed room; cultures for C. difficile will be included if they are obtained within 28 days of discharge from a seed room.
- Clinical incidence rate of C. difficile among patients admitted to a study room [ Time Frame: 28 days ] [ Designated as safety issue: No ]Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.
- Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room. [ Time Frame: 90 days ] [ Designated as safety issue: No ]Patients will be monitored for clinical cultures that grow one of three target vegetative organisms (MRSA, VRE, and MDR-Acinetobacter) following admission to a "seed" room.
- Clinical incidence rate of target organisms among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]All hospitalized patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) regardless of exposure to seed room.
- Clinical incidence rate of MRSA among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]All hospitalized patients will be monitored for clinical cultures that grow MRSA regardless of exposure to seed room.
- Clinical incidence rate of VRE among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]All hospitalized patients will be monitored for clinical cultures that grow VRE regardless of exposure to seed room.
- Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]All hospitalized patients will be monitored for clinical cultures that grow MDR-Acinetobacter regardless of exposure to seed room.
- Clinical incidence rate of C. difficile among all patients admitted to the hospital [ Time Frame: 28 days ] [ Designated as safety issue: No ]All hospitalized patients will be monitored for clinical cultures that grow C. difficile regardless of exposure to seed room.
- Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to MRSA following admission to a "seed" room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to VRE following admission to a "seed" room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to MDR-Acinetobacter following admission to a "seed" room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to MDR-Acinetobacter, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to MRSA, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to VRE, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
- Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]Patients will be monitored for HAIs due to MRSA, VRE, and MDR-Acinetobacter regardless of exposure to seed room. NHSN definitions for HAIs will be used.
- Missed Opportunities [ Time Frame: each study period (6 months) ] [ Designated as safety issue: No ]Use of UV-C emitting devices will be monitored and "missed opportunities" (ie, UV-C emitter should have been used per protocol and was not) will be tracked and summarized. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
- Time on Diversion [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. The proportion will be calculated as the average number of days on diversion per month for each study period. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) will be considered the reference group.
- Room Turnover Time [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]Room cleaning process will be monitored and tracked. We will obtain start and stop times for terminal room cleaning to determine if use of UV-C light emitting devices leads to additional time for room turnover. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
- ED to floor wait time [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
- Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light [ Time Frame: 12 months (2 6-month study arms combined) ] [ Designated as safety issue: No ]The clinical incidence rate of MRSA, VRE, C. difficile, and MDR-Acinetobacter will be calculated for the two 6-month study arms (12 months total) during which UV-C light is used for terminal room disinfection (regardless of which chemical is used) and compared to the two 6-month study arms (12 months total) during which UV-C light is not used for terminal room disinfection.
Estimated Enrollment: | 50000 |
Study Start Date: | April 2012 |
Estimated Study Completion Date: | October 2014 |
Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: Quaternary ammonium
Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.
|
Other: Quaternary ammonium
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
|
Experimental: Bleach
Rooms will be terminally cleaned using bleach-containing products.
|
Other: Bleach
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
|
Experimental: Quaternary ammonium and UV-C light
Rooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device.
|
Other: Quaternary ammonium and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
|
Experimental: Bleach and UV-C light
Rooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device.
|
Other: Bleach and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
|
Detailed Description:
Meticulous and consistent use of hand hygiene before and after patient care remains the cornerstone of infection prevention in all health care settings. However, clean hands are not sufficient to prevent all healthcare-associated infections (HAIs), as 1) hands of healthcare workers easily become contaminated from contact with contaminated environmental surfaces in patient rooms after appropriate hand hygiene has been performed and before direct patient care and 2) direct contact by patients with preexisting contaminated environmental surfaces in their hospital rooms can lead to colonization or infection. Thus, novel strategies are needed to prevent HAIs, particularly those caused by multidrug-resistant (MDR) pathogens that persist in the environment such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Clostridium difficile, and Acinetobacter.
Enhanced environmental disinfection methods may lead to reduced risk of exposure to or acquisition of HAIs and MDR-pathogens and overcome a critical issue facing healthcare today - hospitals rooms are often poorly cleaned and disinfected. Enhanced terminal room disinfection strategies using bleach and/or UV-C emitting devices have been investigated only in experimental conditions; the efficacy, effectiveness, and feasibility of enhanced terminal room disinfection to prevent HAIs are unknown. Thus, the scientific evidence for such interventions currently is insufficient for their inclusion in evidence-based guidelines.
This study will investigate the hypothesis that enhanced terminal room disinfection protocols (using chlorine-based cleaning agents with or without UV-C light-emitting devices) will decrease the overall risk of HAIs in the hospital and, more specifically, in subsequent patients who are cared for in the same room. This prospective investigation will employ a crossover design utilizing four room cleaning/disinfection protocols in 9 hospitals, including 2 tertiary care, 1 VA, and 6 community hospitals. Phase T2 data from this study will be useful in assessing the clinical efficacy and feasibility of individual disinfection strategies. Thus, the goals of the investigators proposed research are to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.
![](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any seed room (ie., room from which a patient with one of the target organisms has been transferred or discharged)
Exclusion Criteria:
- None, intervention is at level of the room, not the patient
- Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.
![](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, North Carolina | |
Alamance Regional Medical Center | |
Burlington, North Carolina, United States, 27215 | |
University of North Carolina Hospitals | |
Chapel Hill, North Carolina, United States, 27514 | |
Durham VA Medical Center | |
Durham, North Carolina, United States, 27710 | |
Durham Regional Hospital | |
Durham, North Carolina, United States, 27704 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
High Point Regional Health System | |
High Point, North Carolina, United States, 27261 | |
Duke Raleigh Hospital | |
Raleigh, North Carolina, United States, 27609 | |
Rex Healthcare | |
Raleigh, North Carolina, United States, 27607 | |
United States, Virginia | |
Chesapeake Regional Medical Center | |
Chesapeake, Virginia, United States, 23320 |
Principal Investigator: | Daniel J Sexton, MD | Duke University |
![](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
![This link exits the ClinicalTrials.gov site](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/exit.bmp)
![This link exits the ClinicalTrials.gov site](https://webarchive.library.unt.edu/web/20121018215800im_/http://www.clinicaltrials.gov/ct2/html/images/frame/exit.bmp)
No publications provided
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01579370 History of Changes |
Other Study ID Numbers: | Pro00032718, 1U54CK000164-01 |
Study First Received: | April 5, 2012 |
Last Updated: | April 16, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
healthcare associated infections multidrug resistant organisms methicillin resistant staphylococcus aureus |
vancomycin resistant enterococcus clostridium difficile acinetobacter |
ClinicalTrials.gov processed this record on October 17, 2012